178 results on '"Tresckow, Bastian"'
Search Results
2. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update
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Dreyling, Martin, Fowler, Nathan Hale, Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, María Ferreri, Andrés José, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Paule, Ines, Zia, Aiesha, Awasthi, Rakesh, Han, Xia, Germano, Davide, O’Donovan, Darragh, Ramos, Roberto, Maier, Harald J., Masood, Aisha, Thieblemont, Catherine, and Schuster, Stephen J.
- Abstract
•Tisagenlecleucel responses in patients with r/r FL remain highly durable a year after primary analysis; no new safety signals were observed.•Low levels of LAG3+CD3+exhausted T cells and higher levels of naïve CD8+T cells were significantly associated with improved outcomes.
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- 2024
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3. CXCR4-targeted Theranostics in Hematooncology: Opportunities and Challenges
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Werner, Rudolf, Haug, Alexander, Buske, Christian, Heidegger, Simon, Illert, Anna L., Bassermann, Florian, Herhaus, Peter, Buck, Andreas, Duell, Johannes, Topp, Max S, Kraus, Sabrina, Einsele, Hermann, Lapa, Constantin, Raderer, Markus, Lenz, Georg, Habringer, Stefan, von Tresckow, Bastian, and Keller, Ulrich
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- 2024
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4. Follow-up of the GHSG HD16 trial of PET-guided treatment in early-stage favorable Hodgkin lymphoma
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Fuchs, Michael, Jacob, Anne Sophie, Kaul, Helen, Kobe, Carsten, Kuhnert, Georg, Pabst, Thomas, Greil, Richard, Bröckelmann, Paul J., Topp, Max S., Just, Marianne, Hertenstein, Bernd, Soekler, Martin, Vogelhuber, Martin, Zijlstra, Josée M., Keller, Ulrich Bernd, Krause, Stefan W., Dührsen, Ulrich, Meissner, Julia, Viardot, Andreas, Eich, Hans-Theodor, Baues, Christian, Diehl, Volker, Rosenwald, Andreas, Buehnen, Ina, von Tresckow, Bastian, Dietlein, Markus, Borchmann, Peter, Engert, Andreas, and Eichenauer, Dennis A.
- Abstract
The primary analysis of the GHSG HD16 trial indicated a significant loss of tumor control with PET-guided omission of radiotherapy (RT) in patients with early-stage favorable Hodgkin lymphoma (HL). This analysis reports long-term outcomes. Overall, 1150 patients aged 18–75 years with newly diagnosed early-stage favorable HL were randomized between standard combined-modality treatment (CMT) (2x ABVD followed by PET/CT [PET-2] and 20 Gy involved-field RT) and PET-2-guided treatment omitting RT in case of PET-2 negativity (Deauville score [DS] < 3). The study aimed at excluding inferiority of PET-2-guided treatment and assessing the prognostic impact of PET-2 in patients receiving CMT. At a median follow-up of 64 months, PET-2-negative patients had a 5-year progression-free survival (PFS) of 94.2% after CMT (n= 328) and 86.7% after ABVD alone (n= 300; HR = 2.05 [1.20–3.51]; p= 0.0072). 5-year OS was 98.3% and 98.8%, respectively (p= 0.14); 4/12 documented deaths were caused by second primary malignancies and only one by HL. Among patients assigned to CMT, 5-year PFS was better in PET-2-negative (n= 353; 94.0%) than in PET-2-positive patients (n= 340; 90.3%; p= 0.012). The difference was more pronounced when using DS4 as cut-off (DS 1-3: n= 571; 94.0% vs. DS ≥ 4: n= 122; 83.6%; p< 0.0001). Taken together, CMT should be considered standard treatment for early-stage favorable HL irrespective of the PET-2-result.
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- 2024
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5. Interim PET-guided treatment for early-stage NLPHL: a subgroup analysis of the randomized GHSG HD16 and HD17 studies
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Eichenauer, Dennis A., Bühnen, Ina, Baues, Christian, Kobe, Carsten, Kaul, Helen, Greil, Richard, Moccia, Alden, Zijlstra, Joseé M., Hertenstein, Bernd, Topp, Max S., Just, Marianne, von Tresckow, Bastian, Eich, Hans-Theodor, Fuchs, Michael, Dietlein, Markus, Hartmann, Sylvia, Engert, Andreas, and Borchmann, Peter
- Abstract
•In early-stage favorable NLPHL, consolidation RT appears necessary to achieve the optimal disease control irrespective of the iPET result.•In early-stage NLPHL, Hodgkin lymphoma–directed approaches result in a 5-year PFS >90% and a 5-year overall survival of 100%.
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- 2023
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6. Nivolumab and Doxorubicin, Vinblastine, and Dacarbazine in Early-Stage Unfavorable Hodgkin Lymphoma: Final Analysis of the Randomized German Hodgkin Study Group Phase II NIVAHL Trial.
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Bröckelmann, Paul J., Bühnen, Ina, Meissner, Julia, Trautmann-Grill, Karolin, Herhaus, Peter, Halbsguth, Teresa V., Schaub, Valdete, Kerkhoff, Andrea, Mathas, Stephan, Bormann, Matthias, Dickhut, Andreas, Kaul, Helen, Fuchs, Michael, Kobe, Carsten, Baues, Christian, Borchmann, Peter, Engert, Andreas, and von Tresckow, Bastian
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- 2023
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7. Hematopoietic stem cell boost for persistent neutropenia after CAR T-cell therapy: a GLA/DRST study
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Gagelmann, Nico, Wulf, Gerald Georg, Duell, Johannes, Glass, Bertram, van Heteren, Pearl, von Tresckow, Bastian, Fischer, Monika, Penack, Olaf, Ayuk, Francis, Einsele, Herrmann, Holtick, Udo, Thomson, Julia, Dreger, Peter, and Kröger, Nicolaus
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Hematotoxicity after chimeric antigen receptor (CAR) T-cell therapy is associated with infection and death but management remains unclear. We report results of 31 patients receiving hematopoietic stem cell boost (HSCB; 30 autologous, 1 allogeneic) for either sustained severe neutropenia of grade 4 (<0.5 × 109/L), sustained moderate neutropenia (≤1.5 × 109/L) and high risk of infection, or neutrophil count ≤2.0 × 109/L and active infection. Median time from CAR T-cell therapy to HSCB was 43 days and median absolute neutrophil count at time of HSCB was 0.2. Median duration of neutropenia before HSCB was 38 days (range, 7-151). Overall neutrophil response rate (recovery or improvement) was observed in 26 patients (84%) within a median of 9 days (95% confidence interval, 7-14). Time to response was significantly associated with the duration of prior neutropenia (P = .007). All nonresponders died within the first year after HSCB. One-year overall survival for all patients was 59% and significantly different for neutropenia (≤38 days; 85%) vs neutropenia >38 days before HSCB (44%; P = .029). In conclusion, early or prophylactic HSCB showed quick response and improved outcomes for sustained moderate to severe neutropenia after CAR-T.
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- 2023
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8. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma
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Salles, Gilles, Schuster, Stephen J., Dreyling, Martin, Fischer, Luca, Kuruvilla, John, Patten, Piers E. M., von Tresckow, Bastian, Smith, Sonali M., Jiménez-Ubieto, Ana, Davis, Keith L., Anjos, Carla, Chu, Jufen, Zhang, Jie, Lobetti Bodoni, Chiara, Thieblemont, Catherine, Fowler, Nathan H., Dickinson, Michael, Martínez-López, Joaquin, Wang, Yucai, and Link, Brian K.
- Abstract
The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory follicular lymphoma (r/r FL). As ELARA is a single-arm trial, this study compares tisa-cel outcomes from the ELARA trial with usual care from a real-world cohort. ELARA enrolled 98 patients as of 29 March 2021 (median follow-up: 15 months from enrollment). Usual care data were obtained from ReCORD-FL, a global retrospective study of patients with r/r FL, who met similar eligibility criteria to ELARA. With a data cutoff date of 31 December 2020, 187 patients with ≥2 preceding treatment lines were included in the ReCORD-FL (median follow-up: 57 months from third-line) study. An indirect treatment comparison was performed for 97 patients from the ELARA trial and 143 patients from the ReCORD-FL study with no missing data on baseline factors. The line of therapy for which outcomes were assessed was selected or matched between cohorts using propensity score modeling. After baseline factor adjustment via weighting by odds, complete response rate (CRR; 95% confidence interval) was 69.1% (59.8%-78.3%) for tisa-cel vs. 37.3% (26.4%-48.3%) for usual care; overall response rate was 85.6% (78.7%-92.5%) vs. 63.6% (52.5%-74.7%). Kaplan-Meier probability of being progression/event-free at 12 months was 70.5% (61.4%-79.7%) for tisa-cel vs. 51.9% (40.6%-63.3%) for usual care, with hazard ratio (HR)=0.60 (0.34-0.86); 12-month overall survival was 96.6% (92.9%-100%) vs. 71.7% (61.2%-82.2%), with HR=0.2 (0.02-0.38). In conclusion, tisa-cel was associated with a 1.9-fold higher complete response rate and a 1.4-fold higher rate of being progression or event free at 12 months vs usual care, as well as a death risk reduction of 80%. The findings provide additional evidence on the benefit of tisa-cel in patients with r/r FL after ≥2 treatment lines. This trial was registered at www.clinicaltrials.gov as NCT03568461
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- 2022
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9. Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma
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Salles, Gilles, Schuster, Stephen J., Dreyling, Martin, Fischer, Luca, Kuruvilla, John, Patten, Piers E. M., von Tresckow, Bastian, Smith, Sonali M., Jiménez-Ubieto, Ana, Davis, Keith L., Anjos, Carla, Chu, Jufen, Zhang, Jie, Lobetti Bodoni, Chiara, Thieblemont, Catherine, Fowler, Nathan H., Dickinson, Michael, Martínez-López, Joaquin, Wang, Yucai, and Link, Brian K.
- Abstract
•Our study contextualizes the single-arm ELARA trial by providing historical control data from clinically similar patients on usual care.•Tisagenlecleucel was shown to have superior efficacy than usual care in patients with multiply relapsed or refractory follicular lymphoma.
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- 2022
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10. Long-Term Clinical Outcomes and Correlative Efficacy Analyses in Patients (Pts) with Relapsed/Refractory Follicular Lymphoma (r/r FL) Treated with Tisagenlecleucel in the Elara Trial
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Dreyling, Martin, Dickinson, Michael, Martinez Lopez, Joaquin, Kolstad, Arne, Butler, Jason P, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio, Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie Jose, Andreadis, Charalambos, Riedell, Peter A., Ho, Phoebe Joy, Perez-Simon, Jose A., Chen, Andy, Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés J M, Teshima, Takanori, Patten, Piers E.M., McGuirk, Joseph P., Petzer, Andreas, Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Paule, Ines, Zia, Aiesha, Awasthi, Rakesh, Han, Xia, Germano, Davide, O'Donovan, Darragh, Ramos, Roberto, Masood, Aisha, Thieblemont, Catherine, Fowler, Nathan H., and Schuster, Stephen J.
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- 2022
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11. Long-Term Clinical Outcomes and Correlative Efficacy Analyses in Patients (Pts) with Relapsed/Refractory Follicular Lymphoma (r/r FL) Treated with Tisagenlecleucel in the Elara Trial
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Dreyling, Martin, Dickinson, Michael, Martinez Lopez, Joaquin, Kolstad, Arne, Butler, Jason P, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio, Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie Jose, Andreadis, Charalambos, Riedell, Peter A., Ho, Phoebe Joy, Perez-Simon, Jose A., Chen, Andy, Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés J M, Teshima, Takanori, Patten, Piers E.M., McGuirk, Joseph P., Petzer, Andreas, Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Paule, Ines, Zia, Aiesha, Awasthi, Rakesh, Han, Xia, Germano, Davide, O'Donovan, Darragh, Ramos, Roberto, Masood, Aisha, Thieblemont, Catherine, Fowler, Nathan H., and Schuster, Stephen J.
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- 2022
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12. Neue Ansätze zur Behandlung des rezidivierten oder refraktären Hodgkin Lymphoms
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Bröckelmann, Paul J., von Tresckow, Bastian, and Engert, Andreas
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Hintergrund: Während das klassische Hodgkin Lymphom (HL) mit risikoadaptierter Erstlinientherapie in den meisten Fällen heilbar ist, stellt v. a. die Therapie von Patient*innen mit rezidiviertem oder primär refraktärem (r/r) HL weiterhin eine Herausforderung dar. Methoden: Der vorliegende Übersichtsartikel diskutiert die aktuell verfügbaren Daten zu Sicherheit und Effektivität neuerer Therapieansätze bei r/r-HL aus einer praxisorientierten Perspektive. Ergebnisse: Bei für eine intensivierte Therapie geeigneten Patient*innen kann in etwa 50 % der Fälle mit einer polychemotherapiebasierten Salvage-Therapie und anschließender Hochdosischemotherapie mit autologer Stammzelltransplantation (ASZT) eine dauerhafte Remission erreicht werden. Durch die Zulassung zielgerichteter Substanzen haben auch Patient*innen mit mehrfach rezidivierten oder refraktären Tumoren, ältere oder multimorbide Patient*innen mittlerweile mehrere Therapieoptionen. Neben dem Anti-CD30-Antikörper-Wirkstoff-Konjugat Brentuximab-Vedotin (BV) kommen hier zunehmend die beiden Anti-PD-1-Antikörper Nivolumab und Pembrolizumab als Immuncheckpointinhibitoren zum Einsatz. Die Anti-PD-1-Antikörper werden auch in früheren Therapielinien eingesetzt; so wurde z. B. mit Pembrolizumab in einer internationalen Phase-III-Studie im Vergleich zu BV bei vergleichbaren Ansprechraten ein signifikant längeres progressionsfreies Überleben (PFS) erreicht. Die Therapielandschaft des r/r-HL befindet sich im raschen Wandel, und vielversprechende zielgerichtete Substanzen wie das Antikörper-Wirkstoff-Konjugat Camidanlumab-Tesirin, neue Checkpointinhibitoren sowie CAR-T-Zellen werden aktuell in Studien erprobt. Schlussfolgerung: Durch rationalen Einsatz der verfügbaren Therapieansätze ist eine verbesserte Prognose für Patient*innen mit mehrfach r/r-HL absehbar.
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- 2022
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13. Cellular therapies in older adults with hematological malignancies: A case-based, state-of-the-art review.
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Neuendorff, Nina Rosa, Khan, Abdullah, Ullrich, Fabian, Yates, Samuel, Devarakonda, Srinivas, Lin, Richard J., von Tresckow, Bastian, Cordoba, Raul, Artz, Andrew, and Rosko, Ashley E.
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Cellular therapies, including autologous stem cell transplant (ASCT), allogeneic hematopoietic cell transplantation (alloHCT), and chimeric antigen receptor- (CAR-) T cell therapies are essential treatment modalities for many hematological malignancies. Although their use in older adults has substantially increased within the past decades, cellular therapies represent intensive treatment approaches that exclude a large percentage of older adults due to comorbidities and frailty. Under- and overtreatment in older adults with hematologic malignancy is a challenge and many treatment decisions are influenced by chronologic age. The advent of efficient and well-tolerated newer treatment approaches for multiple myeloma has challenged the role of ASCT. In the modern era, there are no randomized clinical trials of transplant versus non-transplant strategies for patients ≥65 years. Nonetheless, ASCT is feasible for selected older patients and does not result in long-term compromise in quality of life. AlloHCT is the only curative approach for acute myeloid leukemia of intermediate and unfavourable risk but carries a significant risk for non-relapse mortality depending on comorbidities, general fitness, and transplant-specific characteristics, such as intensity of conditioning and donor choice. However, alloHCT is feasible in appropriately-selected older adults. Early referral for evaluation is strongly encouraged as this is the most obvious barrier. CAR-T cell therapies have shown unprecedented clinical efficacy and durability in relapsed and refractory diffuse large B cell lymphoma. Its use is well tolerated in older adults, although evidence comes from limited case numbers. Whether patients who are deemed unfit for ASCT qualify for CAR-T cell therapy remains elusive, but the tolerability and efficacy of CAR-T cell therapy appears promising, especially for older patients. The evidence from randomized trials is strong in favor of using a comprehensive geriatric assessment (CGA) to reduce treatment-related toxicities and guide treatment intensity in the care for solid tumors; its use for evaluation of cellular therapies is less evidence-based. However, CGA can provide useful information on patients' fitness, resilient mechanisms, and reveal potential optimization strategies for compensating for vulnerabilities. In this narrative review, we will discuss key questions on cellular therapies in older adults based on illustrative patient cases. [ABSTRACT FROM AUTHOR]
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- 2024
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14. GLA/DRST real-world outcome analysis of CAR T-cell therapies for large B-cell lymphoma in Germany
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Bethge, Wolfgang A., Martus, Peter, Schmitt, Michael, Holtick, Udo, Subklewe, Marion, von Tresckow, Bastian, Ayuk, Francis, Wagner-Drouet, Eva Marie, Wulf, Gerald G., Marks, Reinhard, Penack, Olaf, Schnetzke, Ulf, Koenecke, Christian, von Bonin, Malte, Stelljes, Matthias, Glass, Bertram, Baldus, Claudia D., Vucinic, Vladan, Mougiakakos, Dimitrios, Topp, Max, Fante, Matthias A., Schroers, Roland, Bayir, Lale, Borchmann, Peter, Buecklein, Veit, Hasenkamp, Justin, Hanoun, Christine, Thomas, Simone, Beelen, Dietrich W., Lengerke, Claudia, Kroeger, Nicolaus, and Dreger, Peter
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CD19-directed chimeric antigen receptor (CAR) T cells have evolved as a new standard-of-care (SOC) treatment in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Here, we report the first German real-world data on SOC CAR T-cell therapies with the aim to explore risk factors associated with outcomes. Patients who received SOC axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) for LBCL and were registered with the German Registry for Stem Cell Transplantation (DRST) were eligible. The main outcomes analyzed were toxicities, response, overall survival (OS), and progression-free survival (PFS). We report 356 patients who received axi-cel (n = 173) or tisa-cel (n = 183) between November 2018 and April 2021 at 21 German centers. Whereas the axi-cel and tisa-cel cohorts were comparable for age, sex, lactate dehydrogenase (LDH), international prognostic index (IPI), and pretreatment, the tisa-cel group comprised significantly more patients with poor performance status, ineligibility for ZUMA-1, and the need for bridging, respectively. With a median follow-up of 11 months, Kaplan-Meier estimates of OS, PFS, and nonrelapse mortality (NRM) 12 months after dosing were 52%, 30%, and 6%, respectively. While NRM was largely driven by infections subsequent to prolonged neutropenia and/or severe neurotoxicity and significantly higher with axi-cel, significant risk factors for PFS on the multivariate analysis included bridging failure, elevated LDH, age, and tisa-cel use. In conclusion, this study suggests that important outcome determinants of CD19-directed CAR T-cell treatment of LBCL in the real-world setting are bridging success, CAR-T product selection, LDH, and the absence of prolonged neutropenia and/or severe neurotoxicity. These findings may have implications for designing risk-adapted CAR T-cell therapy strategies.
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- 2022
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15. Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up
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Schuster, Stephen J., Fowler, Nathan H., Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andres Jose Maria, Teshima, Takanori, Patten, Piers EM, McGuirk, Joseph P., Petzer, Andreas, Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Paule, Ines, Germano, Davide, Ramos, Roberto, Hsu, Pei, Thieblemont, Catherine, and Dreyling, Martin
- Abstract
Primary analysis of the Phase II ELARA trial (median follow-up: 17 mo) reported high response rates and a favorable safety profile in heavily pretreated patients (pts) with relapsed/refractory follicular lymphoma (r/r FL). Here we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after a median follow-up of more than 3 y.
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- 2024
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16. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial
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Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, José Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Masood, Aisha, Anak, Oezlem, Schuster, Stephen J., and Thieblemont, Catherine
- Abstract
Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8–20.21). The primary endpoint was met. In the efficacy set (n= 94), CRR was 69.1% (95% confidence interval, 58.8–78.3) and ORR 86.2% (95% confidence interval, 77.5–92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n= 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients.
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- 2022
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17. Impact of age on outcome of CAR-T cell therapies for large B-cell lymphoma: the GLA/DRST experience
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Dreger, Peter, Holtick, Udo, Subklewe, Marion, von Tresckow, Bastian, Ayuk, Francis, Wagner, Eva, Wulf, Gerald, Marks, Reinhardt, Penack, Olaf, Schnetzke, Ulf, Koenecke, Christian, von Bonin, Malte, Stelljes, Matthias, Glass, Bertram, Baldus, Claudia D., Vucinic, Vladan, Mougiakakos, Dimitrios, Topp, Max, Schroers, Roland, Wolff, Daniel, Thomas, Simone, Kröger, Nicolaus, and Bethge, Wolfgang A.
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- 2022
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18. Interim FDG-PET analysis to identify patients with aggressive non-Hodgkin lymphoma who benefit from treatment intensification: a post-hoc analysis of the PETAL trial
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Seifert, Robert, Kersting, David, Rischpler, Christoph, Sandach, Patrick, Ferdinandus, Justin, Fendler, Wolfgang P., Rahbar, Kambiz, Weckesser, Matthias, Umutlu, Lale, Hanoun, Christine, Hüttmann, Andreas, Reinhardt, Hans Christian, von Tresckow, Bastian, Herrmann, Ken, Dührsen, Ulrich, and Schäfers, Michael
- Abstract
The randomized PETAL trial failed to demonstrate a benefit of interim FDG-PET (iPET)-based treatment intensification over continued standard therapy with CHOP (plus rituximab (R) in CD20-positive lymphomas). We hypothesized that PET analysis of all lymphoma manifestations may identify patients who benefitted from treatment intensification. A previously developed neural network was employed for iPET analysis to identify the highest pathological FDG uptake (max-SUVAI) and the mean FDG uptake of all lymphoma manifestations (mean-SUVAI). High mean-SUVAIuptake was determined separately for iPET-positive and iPET-negative patients. The endpoint was time-to-progression (TTP). There was a significant interaction of additional rituximab and mean-SUVAIin the iPET-negative group (HR = 0.6, p< 0.05). Patients with high mean-SUVAIhad significantly prolonged TTP when treated with 6xR-CHOP + 2 R (not reached versus 52 months, p< 0.05), whereas max-SUVmanualfailed to show an impact of additional rituximab. In the iPET-positive group, patients with high mean-SUVAIhad a significantly longer TTP with (R-)CHOP than with the Burkitt protocol (14 versus 4 months, p< 0.01). Comprehensive iPET evaluation may provide new prognosticators in aggressive lymphoma. Additional application of rituximab was associated with prolonged TTP in iPET-negative patients with high mean-SUVAI. Comprehensive iPET interpretation could identify high-risk patients who benefit from study-specific interventions.
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- 2022
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19. Nivolumab and AVD in Early-Stage Unfavorable Hodgkin Lymphoma: Follow-up Analysis of the Randomized GHSG Phase II Nivahl Trial
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Bröckelmann, Paul J, Bühnen, Ina, Meissner, Julia, Trautmann-Grill, Karolin, Herhaus, Peter, Halbsguth, Teresa V, Schaub, Valdete, Kerkhoff, Andrea, Mathas, Stephan, Bormann, Matthias, Dickhut, Andreas, Kaul, Helen, Fuchs, Michael, Kobe, Carsten, Baues, Christian, Borchmann, Peter, Engert, Andreas, and von Tresckow, Bastian
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- 2022
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20. Nivolumab and AVD in Early-Stage Unfavorable Hodgkin Lymphoma: Follow-up Analysis of the Randomized GHSG Phase II Nivahl Trial
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Bröckelmann, Paul J, Bühnen, Ina, Meissner, Julia, Trautmann-Grill, Karolin, Herhaus, Peter, Halbsguth, Teresa V, Schaub, Valdete, Kerkhoff, Andrea, Mathas, Stephan, Bormann, Matthias, Dickhut, Andreas, Kaul, Helen, Fuchs, Michael, Kobe, Carsten, Baues, Christian, Borchmann, Peter, Engert, Andreas, and von Tresckow, Bastian
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- 2022
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21. Relapse After Early-Stage, Favorable Hodgkin Lymphoma: Disease Characteristics and Outcomes With Conventional or High-Dose Chemotherapy.
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Bröckelmann, Paul J, Müller, Horst, Guhl, Teresa, Behringer, Karolin, Fuchs, Michael, Moccia, Alden A, Rank, Andreas, Soekler, Martin, Vieler, Tom, Pabst, Thomas, Baues, Christian, von Tresckow, Bastian, Borchmann, Peter, and Engert, Andreas
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- 2021
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22. Intensified treatment of patients with early stage, unfavourable Hodgkin lymphoma: long-term follow-up of a randomised, international phase 3 trial of the German Hodgkin Study Group (GHSG HD14)
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Gillessen, Sarah, Plütschow, Annette, Fuchs, Michael, Markova, Jana, Greil, Richard, Topp, Max S, Meissner, Julia, Zijlstra, Josée M, Eichenauer, Dennis A, Bröckelmann, Paul J, Diehl, Volker, Borchmann, Peter, Engert, Andreas, and von Tresckow, Bastian
- Abstract
To improve the long-term tumour control in early, unfavourable Hodgkin Lymphoma, the German Hodgkin Study Group (GHSG) HD14 trial compared four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) with an intensified chemotherapy regimen consisting of two cycles of escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (escalated BEACOPP) plus two cycles of ABVD. The final analysis of the trial showed a significant advantage in terms of freedom from treatment failure (difference 7·2% [95% CI 3·8–10·5] at 5 years) for patients who received two cycles of escalated BEACOPP and two cycles of ABVD. However, there was no difference in overall survival between the two groups. To evaluate long-term efficacy and toxicity of this strategy, we did a follow-up analysis.
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- 2021
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23. Health-Related Quality of Life in Patients With Hodgkin Lymphoma: A Longitudinal Analysis of the German Hodgkin Study Group.
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Kreissl, Stefanie, Müller, Horst, Goergen, Helen, Meissner, Julia, Topp, Max, Sökler, Martin, Markova, Jana, Bernhard, Jürg, Greil, Richard, von Tresckow, Bastian, Behringer, Karolin, Rüffer, Jens-Ulrich, Flechtner, Hans-Henning, Möstl, Michaela, Fuchs, Michael, Engert, Andreas, Diehl, Volker, and Borchmann, Peter
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- 2020
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24. Long-Term Follow-Up of Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma Treated in the HD7 to HD15 Trials: A Report From the German Hodgkin Study Group.
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Eichenauer, Dennis A., Plütschow, Annette, Fuchs, Michael, Sasse, Stephanie, Baues, Christian, Böll, Boris, von Tresckow, Bastian, Diehl, Volker, Borchmann, Peter, and Engert, Andreas
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- 2020
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25. Pretreatment Vitamin D Deficiency Is Associated With Impaired Progression-Free and Overall Survival in Hodgkin Lymphoma.
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Borchmann, Sven, Cirillo, Melita, Goergen, Helen, Meder, Lydia, Sasse, Stephanie, Kreissl, Stefanie, Bröckelmann, Paul Jan, von Tresckow, Bastian, Fuchs, Michael, Ullrich, Roland Tillmann, and Engert, Andreas
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- 2019
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26. Gene expression-based outcome prediction in advanced stage classical Hodgkin lymphoma treated with BEACOPP
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Jachimowicz, Ron D., Klapper, Wolfram, Glehr, Gunther, Müller, Horst, Haverkamp, Heinz, Thorns, Christoph, Hansmann, Martin Leo, Möller, Peter, Stein, Harald, Rehberg, Thorsten, von Tresckow, Bastian, Reinhardt, H. C., Borchmann, Peter, Chan, Fong Chun, Spang, Rainer, Scott, David W., Engert, Andreas, Steidl, Christian, Altenbuchinger, Michael, and Rosenwald, Andreas
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- 2021
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27. Clinical outcomes of relapsed and refractory Hodgkin lymphoma patients after contemporary first-line treatment: a German Hodgkin Study Group analysis
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Bröckelmann, Paul J., Müller, Horst, Gillessen, Sarah, Yang, Xiaoqin, Koeppel, Larissa, Pilz, Veronika, Marinello, Patricia, Kaskel, Peter, Raut, Monika, Fuchs, Michael, Borchmann, Peter, Engert, Andreas, and von Tresckow, Bastian
- Abstract
To evaluate patterns of rrHL after contemporary first-line treatment we studied 409 patients with first rrHL (HD13: n= 87, HD14: n= 118, HD15: n= 188, HDR3i: n= 51) at a median age of 37.4 years (18.4–76.8) from the GHSG database. Time to first relapse was ≤12 months in 49% and stage III/IV rrHL present in 52% of patients. In total, 291 patients received high-dose chemotherapy and autologous stem-cell transplantation (ASCT) and intended ASCT failed in 38 patients. ASCT was primarily not intended in 80 patients largely due to low risk disease or age/comorbidities. Overall, 10-year progression-free (PFS) and overall survival (OS) rates after first relapse were 48.2% (95% CI 41.9–54.2%) and 59.4% (95% CI 53.0–65.2%), respectively, with significant differences between subgroups. Inferior survival was observed with no ASCT due to advanced age/comorbidities (five-year PFS 36.2%, 95% CI 17.7–55.0%) or failure of salvage therapy (five-year PFS 36.3%, 95% CI 19.7–53.2%). Similarly, presence of primary refractory disease or stage IV at rrHL conferred inferior survival. In patients with low-risk disease, however, survival appeared favorable even without ASCT (10 y PFS 72.6%, 95% CI 53.7–84.8%). We herein confirm the curative potential of current rrHL treatments providing a robust benchmark to evaluate novel therapeutic strategies in rrHL. Approximately 50% of rrHL patients experienced a consecutive relapse.
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- 2021
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28. Tumor and microenvironment response but no cytotoxic T-cell activation in classic Hodgkin lymphoma treated with anti-PD1
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Reinke, Sarah, Bröckelmann, Paul J., Iaccarino, Ingram, Garcia-Marquez, Maria, Borchmann, Sven, Jochims, Franziska, Kotrova, Michaela, Pal, Karol, Brüggemann, Monika, Hartmann, Elena, Sasse, Stephanie, Kobe, Carsten, Mathas, Stephan, Soekler, Martin, Keller, Ulrich, Bormann, Matthias, Zimmermann, Andreas, Richter, Julia, Fuchs, Michael, von Tresckow, Bastian, Borchmann, Peter, Schlößer, Hans, von Bergwelt-Baildon, Michael, Rosenwald, Andreas, Engert, Andreas, and Klapper, Wolfram
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Classic Hodgkin lymphoma (cHL) is the cancer type most susceptible to antibodies targeting programmed cell death protein 1 (PD1) and is characterized by scarce Hodgkin and Reed-Sternberg cells (HRSCs), perpetuating a unique tumor microenvironment (TME). Although anti-PD1 effects appear to be largely mediated by cytotoxic CD8+T cells in solid tumors, HRSCs frequently lack major histocompatibility complex expression, and the mechanism of anti-PD1 efficacy in cHL is unclear. Rapid clinical responses and high interim complete response rates to anti-PD1 based first-line treatment were recently reported for patients with early-stage unfavorable cHL treated in the German Hodgkin Study Group phase 2 NIVAHL trial. To investigate the mechanisms underlying this very early response to anti-PD1 treatment, we analyzed paired biopsies and blood samples obtained from NIVAHL patients before and during the first days of nivolumab first-line cHL therapy. Mirroring the rapid clinical response, HRSCs had disappeared from the tissue within days after the first nivolumab application. The TME already shows a reduction in type 1 regulatory T cells and PD-L1+tumor-associated macrophages at this early time point of treatment. Interestingly, a cytotoxic immune response and a clonal T-cell expansion were not observed in the tumors or peripheral blood. These early changes in the TME were distinct from alterations found in a separate set of cHL biopsies at relapse during anti-PD1 therapy. We identify a unique very early histologic response pattern to anti-PD1 therapy in cHL that is suggestive of withdrawal of prosurvival factors, rather than induction of an adaptive antitumor immune response, as the main mechanism of action.
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- 2020
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29. Tumor and microenvironment response but no cytotoxic T-cell activation in classic Hodgkin lymphoma treated with anti-PD1
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Reinke, Sarah, Bröckelmann, Paul J., Iaccarino, Ingram, Garcia-Marquez, Maria, Borchmann, Sven, Jochims, Franziska, Kotrova, Michaela, Pal, Karol, Brüggemann, Monika, Hartmann, Elena, Sasse, Stephanie, Kobe, Carsten, Mathas, Stephan, Soekler, Martin, Keller, Ulrich, Bormann, Matthias, Zimmermann, Andreas, Richter, Julia, Fuchs, Michael, von Tresckow, Bastian, Borchmann, Peter, Schlößer, Hans, von Bergwelt-Baildon, Michael, Rosenwald, Andreas, Engert, Andreas, and Klapper, Wolfram
- Abstract
Classic Hodgkin lymphoma (cHL) is the cancer type most susceptible to antibodies targeting programmed cell death protein 1 (PD1) and is characterized by scarce Hodgkin and Reed-Sternberg cells (HRSCs), perpetuating a unique tumor microenvironment (TME). Although anti-PD1 effects appear to be largely mediated by cytotoxic CD8+ T cells in solid tumors, HRSCs frequently lack major histocompatibility complex expression, and the mechanism of anti-PD1 efficacy in cHL is unclear. Rapid clinical responses and high interim complete response rates to anti-PD1 based first-line treatment were recently reported for patients with early-stage unfavorable cHL treated in the German Hodgkin Study Group phase 2 NIVAHL trial. To investigate the mechanisms underlying this very early response to anti-PD1 treatment, we analyzed paired biopsies and blood samples obtained from NIVAHL patients before and during the first days of nivolumab first-line cHL therapy. Mirroring the rapid clinical response, HRSCs had disappeared from the tissue within days after the first nivolumab application. The TME already shows a reduction in type 1 regulatory T cells and PD-L1+ tumor-associated macrophages at this early time point of treatment. Interestingly, a cytotoxic immune response and a clonal T-cell expansion were not observed in the tumors or peripheral blood. These early changes in the TME were distinct from alterations found in a separate set of cHL biopsies at relapse during anti-PD1 therapy. We identify a unique very early histologic response pattern to anti-PD1 therapy in cHL that is suggestive of withdrawal of prosurvival factors, rather than induction of an adaptive antitumor immune response, as the main mechanism of action.
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- 2020
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30. Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial
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Bröckelmann, Paul J., Goergen, Helen, Keller, Ulrich, Meissner, Julia, Ordemann, Rainer, Halbsguth, Teresa V., Sasse, Stephanie, Sökler, Martin, Kerkhoff, Andrea, Mathas, Stephan, Hüttmann, Andreas, Bormann, Matthias, Zimmermann, Andreas, Mettler, Jasmin, Fuchs, Michael, von Tresckow, Bastian, Baues, Christian, Rosenwald, Andreas, Klapper, Wolfram, Kobe, Carsten, Borchmann, Peter, and Engert, Andreas
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IMPORTANCE: In early-stage unfavorable classic Hodgkin lymphoma (cHL), conventional therapy induces high cure rates but also relevant acute and long-term toxic effects. Nivolumab is well tolerated and highly effective in relapsed/refractory cHL but has not been adequately studied in first-line treatment of early-stage cHL. The NIVAHL trial evaluated nivolumab in this setting with the aim to develop a highly effective yet tolerable systemic therapy to ultimately mitigate morbidity in patients who survive cHL. OBJECTIVE: To evaluate efficacy of 2 experimental nivolumab-based first-line treatment strategies in patients with early-stage unfavorable cHL. DESIGN, SETTING, AND PARTICIPANTS: This was an open-label, multicenter, phase 2 randomized clinical trial, open between April 2017 and October 2018. The trial took place at 35 trial centers across Germany, ranging from academic centers to private offices. Eligibility was defined by age 18 to 60 years, cHL confirmed by expert pathology review, early-stage unfavorable disease by German Hodgkin Study Group criteria (stage I to II with risk factor[s]), and absence of serious concomitant disease or organ dysfunction. Among 110 enrolled patients, 109 were eligible. INTERVENTIONS: Systemic therapy, per random assignment (1:1) to either concomitant treatment with 4 cycles of nivolumab and doxorubicin, vinblastine, and dacarbazine (N-AVD) or sequential treatment with 4 doses of nivolumab, 2 cycles of N-AVD, and 2 cycles of AVD at standard doses, followed by 30-Gy involved-site radiotherapy. MAIN OUTCOMES AND MEASURES: Complete remission (CR) rate after study treatment, aiming at excluding a CR rate of 80% or lower via a 2-sided 95% CI for each treatment group. RESULTS: Of 109 patients included in this study, 65 (59.6%) were women, and the median (range) age was 27 (18-60) years. At interim staging after 2 cycles of N-AVD or 4 doses of nivolumab monotherapy, 54 of 54 (100%) and 49 of 51 (96%) response-eligible patients, respectively, achieved an objective response, with CR in 47 (87%) and 26 (51%) patients, respectively. Among 101 patients eligible for primary end point analysis, 46 of 51 (90%; 95% CI, 79%-97%) patients receiving concomitant therapy and 47 of 50 (94%; 95% CI, 84%-99%) patients receiving sequential therapy achieved CR after study treatment. With a median follow-up of 13 months, 12-month progression-free survival was 100% for patients receiving concomitant treatment and 98% (95% CI, 95%-100%) for patients receiving sequential therapy. CONCLUSIONS AND RELEVANCE: Both strategies combining nivolumab and AVD are feasible and resulted in high remission rates. Despite narrowly missing the efficacy benchmark in the concomitant group, the excellent 12-month progression-free survival and the unexpectedly high CR rate after 4 doses of nivolumab monotherapy warrant further evaluation of this approach in the first-line treatment of patients with early-stage cHL. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03004833
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- 2020
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31. Rituximab in newly diagnosed stage IA nodular lymphocyte-predominant Hodgkin lymphoma: long-term follow-up of a phase 2 study from the German Hodgkin Study Group
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Eichenauer, Dennis A., Plütschow, Annette, Fuchs, Michael, Hartmann, Sylvia, Hansmann, Martin-Leo, Böll, Boris, von Tresckow, Bastian, Borchmann, Peter, and Engert, Andreas
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- 2020
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32. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087
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Chen, Robert, Zinzani, Pier Luigi, Lee, Hun Ju, Armand, Philippe, Johnson, Nathalie A., Brice, Pauline, Radford, John, Ribrag, Vincent, Molin, Daniel, Vassilakopoulos, Theodoros P., Tomita, Akihiro, von Tresckow, Bastian, Shipp, Margaret A., Lin, Jianxin, Kim, Eunhee, Nahar, Akash, Balakumaran, Arun, and Moskowitz, Craig H.
- Abstract
Programmed death-1 inhibitors are approved for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). We present the 2-year follow-up of the phase 2 KEYNOTE-087 study of pembrolizumab in 210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3). With a median follow-up of 27.6 months, the objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9), the complete response rate (CRR) was 27.6%, and the partial response (PR) rate was 44.3%. Median duration of response was 16.5 months (range, 0.0+ to 27.0+ [+, no progressive disease at last assessment]) in all patients, 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grades 3 and 4 occurred in 25 (12.0%) patients; none resulted in death. Results confirmed effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL. This trial was registered at www.clinicaltrials.gov as #NCT02453594.
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- 2019
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33. Pembrolizumab in relapsed or refractory Hodgkin lymphoma: 2-year follow-up of KEYNOTE-087
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Chen, Robert, Zinzani, Pier Luigi, Lee, Hun Ju, Armand, Philippe, Johnson, Nathalie A., Brice, Pauline, Radford, John, Ribrag, Vincent, Molin, Daniel, Vassilakopoulos, Theodoros P., Tomita, Akihiro, von Tresckow, Bastian, Shipp, Margaret A., Lin, Jianxin, Kim, Eunhee, Nahar, Akash, Balakumaran, Arun, and Moskowitz, Craig H.
- Abstract
Programmed death-1 inhibitors are approved for patients with relapsed or refractory classic Hodgkin lymphoma (RRcHL). We present the 2-year follow-up of the phase 2 KEYNOTE-087 study of pembrolizumab in 210 patients, based on HL progression after autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV; cohort 1); salvage chemotherapy and BV, with ineligibility for SCT owing to chemorefractory disease (cohort 2); and progression after SCT without BV (cohort 3). With a median follow-up of 27.6 months, the objective response rate (ORR) by blinded independent central review was 71.9% (95% CI, 65.3-77.9), the complete response rate (CRR) was 27.6%, and the partial response (PR) rate was 44.3%. Median duration of response was 16.5 months (range, 0.0+ to 27.0+ [+, no progressive disease at last assessment]) in all patients, 22.1 months in cohort 1, 11.1 months in cohort 2, and 24.4 months in cohort 3. Median progression-free survival was not reached in all patients with CR: 13.8 months (95% CI, 12.0-22.1) for patients with PR and 10.9 months (95% CI, 5.6-11.1) for patients with stable disease. Median overall survival was not reached in all patients or in any cohort. Treatment-related adverse events (TRAEs) of any grade occurred in 153 (72.9%) patients; grades 3 and 4 occurred in 25 (12.0%) patients; none resulted in death. Results confirmed effective antitumor activity, durability of response, and manageable safety of pembrolizumab monotherapy in RRcHL, regardless of prior treatment and including chemoresistant cHL. This trial was registered at www.clinicaltrials.govas #NCT02453594.
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- 2019
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34. Real World Results of Brexucabtagene Autoleucel for Patients with Relapsed/Refractory Mantle Cell Lymphoma - First German/Swiss Analysis
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Hess, Georg, Vucinic, Vladan, Rejeski, Kai, Aydilek, Enver, Simon, Linda, Penack, Olaf, Koenecke, Christian, von Bonin, Malte, von Tresckow, Bastian, Fehr, Martin, Pott, Christiane, Stilgenbauer, Stephan, Leng, Corinna, Schroers, Roland, Duell, Johannes, Marks, Reinhard, Mueller, Fabian, Brunnberg, Uta, Kerkhoff, Andrea, Ohler, Anke, Wagner Drouet, Eva-Maria, Schmidtmann, Irene, Theobald, Matthias, Dreyling, Martin, and Dreger, Peter
- Abstract
Background: Chimeric antigen receptor T-cells have revolutionized treatment in many B-cell neoplasias. In MCL, brexucabtagene autoleucel (brexu-cel) has been the first product approved based on results of the ZUMA-2 trial for patients failing prior chemoimmunotherapy and BTK-inhibitor. However, in ZUMA-2, strict criteria have been used for patient selection, e.g. no use of intensive bridging/holding treatment was allowed, excluding patients with high treatment needs. In contrast to this, in the real-world scenario patient selection is much more diverse questioning whether the results of controlled trials can be reproduced in the regular treatment landscape. In this intent, we have analyzed the results obtained with brexu-cel as standard-of-care treatment (SOC) of r/r MCL in Germany and Switzerland.
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- 2023
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35. Key Prognostic Factors in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: An Evidence Based Systematic Literature and Medical Review
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von Tresckow, Bastian, Costa, Pau Abrisqueta, Aggarwal, Shivani, Hampp, Christian, Walsh, Laura, Thorley, Eileen, Shah, Mohsin, Ma, Qiufei, and Jimenez Ubieto, Ana
- Abstract
Introduction:A multi-center multi-country retrospective cohort study (ORCHID [NCT05338879]), using real-world data (RWD) from electronic medical records (EMRs) and research databases, for patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with standard of care is being conducted to contextualize treatment outcomes in a single-arm trial. A systematic literature review (SLR) was carried out to identify baseline prognostic factors that will be evaluated for imbalances between cohorts in the single-arm trial and RWD study. This SLR was followed by an evidence-based clinical expert review of prognostic variables and ranking in order of importance for the ORCHID study as described herein.
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- 2023
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36. Efficacy of CD19-Directed CAR T Cell Therapy in Patients with Primary or Secondary CNS Lymphoma - an Analysis of the EBMT Lymphoma WP and the Gocart Coalition
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Ossami Saidy, Anna, Fuhrmann, Stephan, Peczynski, Christophe, Boumendil, Ariane, Michel, Eva, Galimard, Jacques-Emmanuel, Finel, Hervé, Daskalakis, Michael, Novak, Urban, Beauvais, David, Vandenberghe, Peter, Kröger, Nicolaus, Ram, Ron, Finke, Jürgen, Stelljes, Matthias, Wulf, Gerald G., Bethge, Wolfgang Andreas, von Bonin, Malte, Bug, Gesine, Kuhnl, Andrea, Passweg, Jakob, Stoelzel, Friedrich, von Tresckow, Bastian, Sureda Balari, Anna Maria, Dreger, Peter, Schmitz, Norbert, and Glass, Bertram
- Abstract
Introduction: The prognosis of patients (pts) with relapsed or refractory (r/r) large B cell lymphoma (LBCL) and central nervous system (CNS) involvement is dismal. Standard treatment for pts with r/r LBCL are anti-CD19 chimeric antigen receptor T-cells (CART). Several reports with limited numbers of patients suggest that CART might also be an effective treatment for pts with CNS lymphoma. This EBMT registry study aimed at compiling data to investigate the potential of CART in pts with primary (PCNSL) or secondary CNS lymphoma (SCNCL).
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- 2023
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37. An In VivoPiggyBacInsertional Mutagenesis Screen Reveals Oncogenic Lesions Cooperating with Myd88 L265P
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Höfmann, Svenja, Flümann, Ruth, Hansen, Julia, Klein, Sebastian, Meinel, Jörn, Pfeiffer, Pauline, Goldfarb-Wittkopf, Hannah, Lütz, Anna, Wirtz, Jessica, Möllmann, Michael, Zhou, Tanja, Tabatabai, Areya, Lohmann, Tim, Beleggia, Filippo, Pelzer, Benedikt, Ullrich, Fabian, Arora, Aastha, Persigehl, Thorsten, Büttner, Reinhard, von Tresckow, Bastian, Jachimowicz, Ron, Knittel, Gero, and Reinhardt, Hans Christian
- Abstract
Diffuse large B cell lymphoma (DLBCL) is the most common Non-Hodgkin lymphoma and originates from transformed germinal center-experienced B cells. Traditionally, DLBCL has been divided into two subtypes, depending on whether the transcriptional profile of the tumor relates to an activated B cell or a germinal center B cell (ABC and GCB DLBCL, Alizadeh et al., 2000). More recent efforts classified DLBCL cases based on their genetic aberrations and identified several clusters with distinct mutational profiles (Chapuy et al., 2018, Schmitz et al., 2018, Wright et al., 2020). The MCD/C5 cluster is characterized by recurrent mutations in MYD88, PRDM1and frequent amplifications of BCL2, amongst others. We recently showed that mice harboring a B cell-specific Myd88 L252Pmutation (orthologous position of the human p.L265P mutation) develop B cell proliferation and occasional transformation into DLBCL (Knittel et al., 2016). Lymphomagenesis is further increased when Myd88 L252Pis combined with BCL2overexpression and a genetically engineered block in plasmacytic differentiation by loss of Prdm1or overexpression of Spib(Flümann et al., 2021).
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- 2023
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38. Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up
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Schuster, Stephen J, Fowler, Nathan, Dickinson, Michael, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio C, Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A, Ho, Phoebe Joy, Perez-Simon, Jose A., Chen, Andy, Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrés José María, Teshima, Takanori, Patten, Piers, McGuirk, Joseph P, Petzer, Andreas L, Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Paule, Ines, Germano, Davide, Ramos, Roberto Javier, Hsu, Pei, Thieblemont, Catherine, and Dreyling, Martin
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Background: Tisagenlecleucel is approved in the United States and Europe for adults with relapsed/refractory follicular lymphoma (r/r FL) after ≥2 lines of prior therapy. The primary analysis of the Phase II ELARA trial (median follow-up: 17 months) reported high response rates and a favorable safety profile in heavily pretreated patients with r/r FL. Here we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after a median follow-up of more than 3 years.
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- 2023
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39. Tafasitamab and Lenalidomide in Relapsed/Refractory B-Cell Lymphoma: A Multicenter Retrospective Real-World-Study of Patients from Germany and Austria
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Ruckdeschel, Anna, Sabrina, Koemm, Topp, Max S., Greil, Richard, Melchardt, Thomas, Lenz, Georg, Kerkhoff, Andrea, Shumilov, Evgenii, Hess, Georg, Baumgaertner, Marta, Thurner, Lorenz, Age Kos, Igor, Mayer, Stephanie, Ayuk, Francis A., Krause, Rolf, Herling, Marco, Vucinic, Vladan, Chapuy, Claudia, Illerhaus, Gerald, Knott, Markus, Viardot, Andreas, Grunenberg, Alexander, Dietrich, Sascha, Caille, Leandra, Tometten, Mareike C., Cho, Hyunyee Rosa, Scholz, Julia, Mueller, Fabian, Prochazka, Katharina, Chapuy, Bjoern, Böckle, David, von Tresckow, Bastian, Schub, Natalie, Gelbrich, Götz, Einsele, Hermann, and Duell, Johannes
- Abstract
Background
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- 2023
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40. Fertility and Gonadal Function after First-Line Treatment with Nivolumab-AVD in Hodgkin Lymphoma Patients: An Analysis from the Phase II GHSG Nivahl Trial
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Bröckelmann, Paul J, Bühnen, Ina, Herhaus, Peter, Meissner, Julia, Trautmann-Grill, Karolin, Müller, Horst, Fuchs, Michael, von Tresckow, Bastian, Borchmann, Peter, Engert, Andreas, and Behringer, Karolin
- Abstract
Background: First-line treatment of patients with classical Hodgkin lymphoma (HL) with anti-PD1 antibodies in combination with AVD chemotherapy is highly effective across risk-groups. Based on encouraging phase II and ongoing phase III trials, anti-PD1 based first-line treatment may hence soon become a first-line treatment option. To date, no data on fertility and gonadal function after anti-PD1 based first-line HL treatment is available. Herein, we present data on pregnancies and gonadal function in patients treated within the randomized GHSG phase II NIVAHL trial.
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- 2023
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41. Correlation between Progression-Free Survival and Overall Survival in Patients with Relapsed Hodgkin Lymphoma: An Analysis of Individual Patient Data from Randomized GHSG Trials
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Bröckelmann, Paul J, Müller, Horst, Gillessen, Sarah, Jacob, Anne Sophie, Momotow, Jesko, Damaschin, Carla, Ferdinandus, Justin, Yang, Xiaoqin, Fuchs, Michael, Kobe, Carsten, Eich, Hans Theodor, Engert, Andreas, Borchmann, Peter, and von Tresckow, Bastian
- Abstract
Background: Progression-free survival (PFS) and overall survival (OS) are predominant measures of treatment efficacy in Hodgkin lymphoma (HL). Despite preference for OS from many regulatory authorities, PFS is most relevant to patients and frequently serves as primary endpoint in clinical trials. Recently we found a strong correlation between treatment effects on PFS and OS in the first-line setting (Bröckelmann PJ et al. EHA23/ICML23). However, their relationship in the relapsed setting remains unclear. We aimed to evaluate the correlation of PFS with OS after treatment of relapsed HL.
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- 2023
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42. Predictive Value of Positron Emission Tomography/Computed Tomography After ABVD-Based Chemotherapy in Early-Stage Hodgkin Lymphoma.
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Kobe, Carsten, Goergen, Helen, Fuchs, Michael, Müller, Horst, Baues, Christan, Engert, Andreas, Dietlein, Markus, von Tresckow, Bastian, and Borchmann, Peter
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- 2019
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43. Outcome of Patients With Early-Stage Infradiaphragmatic Hodgkin Lymphoma: A Comprehensive Analysis From the German Hodgkin Study Group.
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Sasse, Stephanie, Goergen, Helen, Plütschow, Annette, Böll, Boris, Eichenauer, Dennis A., Fuchs, Michael, Behringer, Karolin, Zijlstra, Joseé M., Greil, Richard, Markova, Jana, Topp, Max S., Meissner, Julia, Neubauer, Andreas, Baues, Christian, Engert, Andreas, Borchmann, Peter, von Tresckow, Bastian, Plütschow, Annette, Böll, Boris, and Zijlstra, Joseé M
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- 2018
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44. Relapsed and refractory nodular lymphocyte-predominant Hodgkin lymphoma: an analysis from the German Hodgkin Study Group
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Eichenauer, Dennis A., Plütschow, Annette, Schröder, Lena, Fuchs, Michael, Böll, Boris, von Tresckow, Bastian, Diehl, Volker, Borchmann, Peter, and Engert, Andreas
- Abstract
The optimal treatment of patients with relapsed or refractory nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is ill defined. To shed more light on treatment options and outcome, we performed an analysis using the database of the German Hodgkin Study Group (GHSG). Ninety-nine patients who had received first-line treatment within 12 prospective GHSG studies conducted between 1993 and 2009, and subsequently developed disease recurrence (n = 91) or had primary disease progression (n = 8), were included. At initial NLPHL diagnosis, the median age was 40 years and 76% of patients were male. First-line treatment consisted of radiotherapy (RT) alone (20%), chemotherapy with or without RT (74%), and the anti-CD20 antibody (Ab) rituximab (6%), respectively. The median follow-up from initial diagnosis was 11.2 years. The median time to disease recurrence was 3.7 years. The applied salvage approaches included single-agent anti-CD20 Ab treatment or RT alone (37%), conventional chemotherapy (CT) with or without anti-CD20 Ab treatment with or without RT (27%) and high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) (31%). No salvage treatment was given in 4% of patients. The 5-year progression-free survival and overall survival estimates after NLPHL recurrence were 75.6% and 89.5% (74.1% and 97.2% after single-agent anti-CD20 Ab treatment or RT alone; 68.0% and 77.8% after CT with or without anti-CD20 Ab treatment with or without RT; 84.6% and 89.8% after HDCT and ASCT). Hence, patients with relapsed or refractory NLPHL had a good overall prognosis. Factors such as time to disease recurrence and previous treatment may guide the choice of the optimal salvage approach for the individual patient.
- Published
- 2018
- Full Text
- View/download PDF
45. Relapsed and refractory nodular lymphocyte-predominant Hodgkin lymphoma: an analysis from the German Hodgkin Study Group
- Author
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Eichenauer, Dennis A., Plütschow, Annette, Schröder, Lena, Fuchs, Michael, Böll, Boris, von Tresckow, Bastian, Diehl, Volker, Borchmann, Peter, and Engert, Andreas
- Abstract
The optimal treatment of patients with relapsed or refractory nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) is ill defined. To shed more light on treatment options and outcome, we performed an analysis using the database of the German Hodgkin Study Group (GHSG). Ninety-nine patients who had received first-line treatment within 12 prospective GHSG studies conducted between 1993 and 2009, and subsequently developed disease recurrence (n = 91) or had primary disease progression (n = 8), were included. At initial NLPHL diagnosis, the median age was 40 years and 76% of patients were male. First-line treatment consisted of radiotherapy (RT) alone (20%), chemotherapy with or without RT (74%), and the anti-CD20 antibody (Ab) rituximab (6%), respectively. The median follow-up from initial diagnosis was 11.2 years. The median time to disease recurrence was 3.7 years. The applied salvage approaches included single-agent anti-CD20 Ab treatment or RT alone (37%), conventional chemotherapy (CT) with or without anti-CD20 Ab treatment with or without RT (27%) and high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) (31%). No salvage treatment was given in 4% of patients. The 5-year progression-free survival and overall survival estimates after NLPHL recurrence were 75.6% and 89.5% (74.1% and 97.2% after single-agent anti-CD20 Ab treatment or RT alone; 68.0% and 77.8% after CT with or without anti-CD20 Ab treatment with or without RT; 84.6% and 89.8% after HDCT and ASCT). Hence, patients with relapsed or refractory NLPHL had a good overall prognosis. Factors such as time to disease recurrence and previous treatment may guide the choice of the optimal salvage approach for the individual patient.
- Published
- 2018
- Full Text
- View/download PDF
46. 68 Ga-FAPI-46 PET for cancer imaging: A prospective single-arm clinical trial.
- Author
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Fendler, Wolfgang P., Bartel, Timo, Pabst, Kim M., Hamacher, Rainer, Hirmas, Nader, Seifert, Robert, Kasper, Stefan, Nader, Michael, Kesch, Claudia, von Tresckow, Bastian, Berliner, Christoph, Kuemmel, Sherko, Harter, Philipp, Reinacher-Schick, Anke C., Lugnier, Celine, Uhl, Waldemar, Hadaschik, Boris A., Siveke, Jens T., Grünwald, Viktor, and Herrmann, Ken
- Published
- 2023
- Full Text
- View/download PDF
47. Brentuximab vedotin-containing escalated BEACOPP variants for newly diagnosed advanced-stage classical Hodgkin lymphoma: follow-up analysis of a randomized phase II study from the German Hodgkin Study Group
- Author
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Damaschin, Carla, Goergen, Helen, Kreissl, Stefanie, Plütschow, Annette, Breywisch, Frank, Mathas, Stephan, Meissner, Julia, Sökler, Martin, Topp, Max S., Vucinic, Vladan, Zimmermann, Andreas, von Tresckow, Bastian, Fuchs, Michael, Engert, Andreas, Borchmann, Peter, and Eichenauer, Dennis A.
- Published
- 2021
- Full Text
- View/download PDF
48. Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 Elara Trial
- Author
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Fowler, Nathan H, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason P, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, Jose Antonio, Nagle, Sarah J., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andres JM, Teshima, Takanori, Patten, Piers, McGuirk, Joseph P., Petzer, Andreas, Offner, Fritz C., Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Bubuteishvili Pacaud, Lida, Forcina, Alessandra, Zia, Aiesha, Schuster, Stephen J., and Thieblemont, Catherine
- Abstract
Fowler: TG Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche: Research Funding. Dickinson:Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy, Honoraria, Research Funding, Speakers Bureau; Merck Sharp & Dohme: Consultancy; Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau. Dreyling:Astra Zeneca: Consultancy; Abbvie: Research Funding; Roche: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy, Research Funding, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Beigene: Consultancy; Gilead: Consultancy, Research Funding, Speakers Bureau; Janssen: Consultancy, Research Funding, Speakers Bureau; Novartis: Consultancy. Martinez-Lopez:Janssen: Consultancy, Honoraria; Novartis: Consultancy; Janssen-cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Research Funding; Incyte: Consultancy, Research Funding. Kolstad:Merck: Research Funding; Nordic Nanovector: Membership on an entity's Board of Directors or advisory committees, Research Funding. Popplewell:Pfizer: Research Funding; Novartis: Research Funding; Roche: Research Funding. Chavez:Genentech: Speakers Bureau; Epizyme: Speakers Bureau; Gilead: Consultancy; Verastem: Consultancy; AbbVie: Consultancy; Karyopharm: Consultancy; BeiGene: Speakers Bureau; Novartis: Consultancy; Kite, a Gilead Company: Consultancy, Speakers Bureau; Pfizer: Consultancy; AstraZeneca: Speakers Bureau; Morphosys: Consultancy, Speakers Bureau; Merck: Research Funding; Bayer: Consultancy; Celgene: Consultancy. Bachy:Beigene: Membership on an entity's Board of Directors or advisory committees; Roche, Celgene, Amgen, Janssen, Gilead, Novartis, Sanofi: Honoraria; Amgen: Research Funding; Roche, Gilead: Consultancy. Kato:AbbVie, AstraZeneca, Celgene, Chugai, Eisai, Janssen, and Novartis: Consultancy; hugai, Takeda, Kyowa-Kirin, Abbvie, Novartis, Eisai, Janssen, Celgene, Ono: Research Funding; Chugai, Takeda, MSD, Kyowa-Kirin, Janssen, Celgene, Ono, Mundi, Dainippon-Sumitomo, Novartis: Honoraria. Harigae:Novartis, Chugai, BMS: Honoraria. Kersten:BMS: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Celgene: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Amgen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen/Cilag: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Miltenyi Biotech: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Takeda: Research Funding; Roche: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Research Funding; Kite/Gilead: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); MSD: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Novartis: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company). Andreadis:Novartis: Research Funding; Gilead/Kite: Consultancy; Merck: Research Funding; Incyte: Consultancy; Karyopharm: Honoraria; Jazz Pharmaceuticals: Honoraria; BMS/Celgene/Juno: Honoraria, Research Funding; Genentech: Consultancy, Current equity holder in publicly-traded company. Riedell:Bayer: Honoraria; Karyopharm Therapeutics: Honoraria; Morphosys: Research Funding; Celgene/Bristol-Myers Squibb Company: Honoraria, Research Funding; Verastem Oncology: Honoraria; Kite Pharmaceuticals/Gilead: Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding. Nastoupil:Karus Therapeutics: Research Funding; Gamida Cell: Honoraria; Gilead/KITE: Honoraria; Novartis: Honoraria, Research Funding; Merck: Research Funding; Celgene: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding; Bayer: Honoraria; Janssen: Honoraria, Research Funding; LAM Therapeutics: Research Funding; TG Therapeutics: Honoraria, Research Funding; Genentech, Inc.: Honoraria, Research Funding. von Tresckow:Takeda: Honoraria, Other: Travel support, Research Funding; Amgen: Honoraria; Pfizer: Honoraria; Kite/Gilead: Honoraria; Roche: Honoraria; MSD Sharp & Dohme: Honoraria, Research Funding; Takeda: Honoraria, Other: Travel support, Research Funding; Novartis: Other: Travel support, Research Funding. Ferreri:Morphosys: Research Funding; Hutchinson: Research Funding; BMS: Research Funding; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding. Teshima:Sharp & Dohme Corp: Consultancy, Honoraria; Bristol-Myers Squibb: Honoraria; Pfizer Japan Inc.: Honoraria; Kyowa Kirin Co., Ltd.: Honoraria, Research Funding; TEIJIN PHARMA LIMITED: Honoraria; The Center of Innovation Program from Japan Science and Technology Agency: Other; Fuji Pharma Co., Ltd.: Honoraria; NIPPON SHINYAKU CO., LTD.: Honoraria; Janssen Pharmaceutical K.K.: Other; Japan Society for the Promotion of Science KAKENHI (17H04206): Other; Novartis Pharma K.K.: Consultancy, Other: Manuscript preparation, Research Funding; Takeda Pharmaceutical Company Limited: Consultancy, Honoraria; Chugai Pharmaceutical Co., Ltd.: Research Funding; Astellas Pharma Inc.: Research Funding; Merck: Consultancy, Honoraria; Sanofi K.K.: Research Funding. Patten:Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Astra Zeneca: Honoraria; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria. McGuirk:Novartis: Research Funding; Fresenius Biotech: Research Funding; Astellas: Research Funding; Juno Therapeutics: Consultancy, Honoraria, Research Funding; Allo Vir: Consultancy, Honoraria, Research Funding; Kite Pharmaceuticals: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pluristem Ltd: Research Funding; Gamida Cell: Research Funding; Bellicum Pharmaceutical: Research Funding. Petzer:Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kite-Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Viardot:Amgen: Honoraria, Other: advisory board; Novartis: Honoraria, Other: advisory board; Kite/Gilead: Honoraria, Other: advisory board; Roche: Honoraria, Other: advisory board. Zinzani:ADC Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; EUSA Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sandoz: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Kyowa Kirin: Consultancy, Speakers Bureau; Eusapharma: Consultancy, Speakers Bureau; Verastem: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kirin Kyowa: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics, Inc.: Honoraria, Speakers Bureau; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Celltrion: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Malladi:Novartis: Consultancy, Honoraria. Bubuteishvili Pacaud:Novartis: Current Employment. Forcina:Novartis: Current Employment. Zia:Novartis: Current Employment. Schuster:Novartis, Genentech, Inc./ F. Hoffmann-La Roche: Research Funding; AlloGene, AstraZeneca, BeiGene, Genentech, Inc./ F. Hoffmann-La Roche, Juno/Celgene, Loxo Oncology, Nordic Nanovector, Novartis, Tessa Therapeutics: Consultancy, Honoraria. Thieblemont:Cellectis: Speakers Bureau; Roche, Amgen, Kyte Gilead, Celgene, Abbvie, Novartis, Cellectis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel support; Roche, Hospita: Research Funding.
- Published
- 2020
- Full Text
- View/download PDF
49. Efficacy and Safety of Tisagenlecleucel in Adult Patients with Relapsed/Refractory Follicular Lymphoma: Interim Analysis of the Phase 2 Elara Trial
- Author
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Fowler, Nathan H, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason P, Ghosh, Monalisa, Popplewell, Leslie L., Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie José, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Pérez-Simón, Jose Antonio, Nagle, Sarah J., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andres JM, Teshima, Takanori, Patten, Piers, McGuirk, Joseph P., Petzer, Andreas, Offner, Fritz C., Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Bubuteishvili Pacaud, Lida, Forcina, Alessandra, Zia, Aiesha, Schuster, Stephen J., and Thieblemont, Catherine
- Abstract
Background:Follicular lymphoma (FL) remains an incurable disease for most patients (pts), characterized by a relapsing and remitting pattern. For pts with relapsed/refractory (r/r) FL, treatment outcomes typically worsen with each subsequent line of therapy, highlighting an unmet need. Tisagenlecleucel (tisa-cel) has demonstrated clinical benefits and manageable safety in pediatric and young adult pts with r/r B-cell acute lymphoblastic leukemia and adult pts with r/r diffuse large B-cell lymphoma. In a prior phase (Ph) 2a study of 14 pts with r/r FL, 71% achieved durable complete remission with tisa-cel (Chong et al. ICML 2019). Here we present a planned interim analysis of ELARA, a Ph 2, international trial of tisa-cel in adults with r/r FL.
- Published
- 2020
- Full Text
- View/download PDF
50. Novel Autochthonous Mouse Models of Serve As Preclinical Tools to Investigate Pathogenesis and Treatment of MCD/C5 DLBCL
- Author
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Flümann, Ruth, Hansen, Julia, Pelzer, Benedikt, Kisis, Ilmars, Lohmann, Tim, Persigehl, Thorsten, Abedpour, Nima, Peifer, Martin, Buettner, Reinhard, von Tresckow, Bastian, Jachimowicz, Ron, Reinhardt, Hans Christian, and Knittel, Gero
- Published
- 2022
- Full Text
- View/download PDF
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