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2. Brentuximab vedotin plus cyclophosphamide, doxorubicin, etoposide, and prednisone followed by brentuximab vedotin consolidation in CD30-positive peripheral T-cell lymphomas: a multicentre, single-arm, phase 2 study

Author

Herrera, Alex F, Zain, Jasmine, Savage, Kerry J, Feldman, Tatyana, Brammer, Jonathan E, Chen, Lu, Puverel, Sandrine, Popplewell, Leslie, Budde, Lihua Elizabeth, Mei, Matthew, Hosing, Chitra, Nair, Ranjit, Leslie, Lori, Daniels, Shari, Peters, Lacolle, Forman, Stephen, Rosen, Steven, Kwak, Larry, and Iyer, Swaminathan P

Published
2024
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4. Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update

Author

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.

Published
2024
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7. Pembrolizumab plus vorinostat induces responses in patients with Hodgkin lymphoma refractory to prior PD-1 blockade

Author

Mei, Matthew, Chen, Lu, Godfrey, James, Song, Joo, Egelston, Colt, Puverel, Sandrine, Budde, L. Elizabeth, Armenian, Saro, Nikolaenko, Liana, Nwangwu, Mary, Guo, Weihua, Gao, Lei, Lee, Peter, Chen, Robert, Daniels, Shari, Kennedy, Neena, Peters, Lacolle, Zain, Jasmine, Rosen, Steven, Forman, Stephen, Popplewell, Leslie, Kwak, Larry, and Herrera, Alex F.

Published
2023
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9. A Phase I Study of the Combination of Rituximab and Ipilimumab in Patients with Relapsed/Refractory B-Cell Lymphoma

Author

Tuscano, Joseph M, Maverakis, Emanual, Groshen, Susan, Tsao-Wei, Denice, Luxardi, Guillaume, Merleev, Alexander A, Beaven, Anne, DiPersio, John F, Popplewell, Leslie, Chen, Robert, Kirschbaum, Mark, Schroeder, Mark A, and Newman, Edward M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Lymphoma, Cancer, Clinical Research, Hematology, Clinical Trials and Supportive Activities, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Humans, Ipilimumab, Lymphoma, B-Cell, Male, Middle Aged, Neoplasm Recurrence, Local, Prognosis, Rituximab, Salvage Therapy, Survival Rate, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeBased on the potential for ipilimumab (I) to augment T-cell activation, we hypothesize that ipilimumab would augment the efficacy of rituximab (R) in patients with relapsed/refractory (R/R) CD20+non-Hodgkin's lymphoma (NHL). This phase I study aimed to identify a recommended phase 2 dose, document toxicities, and preliminarily assess efficacy and potential predictive biomarkers.Patients and methodsThirty-three patients with R/R CD20+B-cell lymphoma received R at 375 mg/m2weekly for 4 weeks and I at 3 mg/kg on day 1 and every 3 weeks for four doses. Responding patients went on to maintenance with each agent given every 12 weeks. To facilitate correlative analysis, the expansion phase randomized patients to simultaneous R+I versus R with I delayed 2 weeks.ResultsToxicity was manageable; no dose-limiting toxicity was observed at the doses studied. When considering the entire cohort, efficacy was modest, with an objective response rate (ORR) of 24% and median progression-free survival (PFS) of 2.6 months. However, in follicular lymphoma patients, the ORR was 58% with a median PFS of 5.6 months. The randomized comparison of R with R+I demonstrated that R+I resulted in more effective B-cell depletion (BCD). Both B-cell depletion and the ratio of CD45RA-regulatory T cell (Treg) to Treg were associated with response at all time points.ConclusionsThe combination of R+I has manageable toxicity and encouraging efficacy in R/R follicular lymphoma. The ratio of CD45RA-Tregs to total Tregs, and peripheral BCD should be studied further as potential predictors of response.

Published
2019

10. Brentuximab vedotin plus nivolumab after autologous haematopoietic stem-cell transplantation for adult patients with high-risk classic Hodgkin lymphoma: a multicentre, phase 2 trial

Author

Herrera, Alex F, Chen, Lu, Nieto, Yago, Holmberg, Leona, Johnston, Patrick, Mei, Matthew, Popplewell, Leslie, Armenian, Saro, Cao, Thai, Farol, Leonardo, Sahebi, Firoozeh, Spielberger, Ricardo, Chen, Robert, Nademanee, Auayporn, Puverel, Sandrine, Nwangwu, Mary, Lee, Peter, Song, Joo, Skarbnik, Alan, Kennedy, Neena, Peters, Lacolle, Rosen, Steven T, Kwak, Larry W, Forman, Stephen J, and Feldman, Tatyana

Published
2023
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16. Response-adapted anti-PD-1–based salvage therapy for Hodgkin lymphoma with nivolumab alone or in combination with ICE

Author

Mei, Matthew G., Lee, Hun Ju, Palmer, Joycelynne M., Chen, Robert, Tsai, Ni-Chun, Chen, Lu, McBride, Kathryn, Smith, D. Lynne, Melgar, Ivana, Song, Joo Y., Bonjoc, Kimberley-Jane, Armenian, Saro, Nwangwu, Mary, Lee, Peter P., Zain, Jasmine, Nikolaenko, Liana, Popplewell, Leslie, Nademanee, Auayporn, Chaudhry, Ammar, Rosen, Steven, Kwak, Larry, Forman, Stephen J., and Herrera, Alex F.

Published
2022
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17. Prognostic significance of fludeoxyglucose positron emission tomography delta radiomics following bridging therapy in patients with large B-cell lymphoma undergoing CART-cell therapy.

Author

Ladbury, Colton, Claire Hao, Watkins, William Tyler, Sampath, Sagus, Jeffrey Wong, Amini, Arya, Sokolov, Karen, Jekwon Yeh, Al Feghali, Karine A., Dorine de Jong, Maniyedath, Arjun, Shirvani, Shervin, Nikolaenko, Liana, Matthew Mei, Herrera, Alex, Popplewell, Leslie, Budde, Lihua Elizabeth, and Dandapani, Savita

Abstract

Purpose/objective(s): Bridging radiation therapy (bRT) is increasingly being utilized prior to chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma (LBCL). It is unknown how the extent of cytoreduction during bRT impacts outcomes. Materials/methods: We retrospectively reviewed patients with LBCL treated with bRT followed by CAR T-cell therapy. Metabolic tumor volume (MTV), maximum standardized uptake value (SUVmax), SUVmean, and total lesion glycolysis (TLG) were extracted from F18-fluorodeoxyglucose positron emission tomography (PET) scans acquired prior to bRT and between completion of bRT and CAR Tcell infusion. Delta radiomics based on changes of these values were then calculated. The association between delta radiomics and oncologic outcomes [progression-free survival (PFS), freedom from distant progression (FFDP), and local control (LC)] were then examined. Results: Thirty-three sites across 23 patients with LBCL were irradiated. All metabolically active disease was treated in 10 patients. Following bRT, median overall decreases (including unirradiated sites) in MTV, SUVmax, SUVmean, and TLG were 22.2 cc (63.1%), 8.9 (36.8%), 3.4 (31.1%), and 297.9 cc (75.8%), respectively. Median decreases in MTV, SUVmax, SUVmean, and TLG in irradiated sites were 15.6 cc (91.1%), 17.0 (74.6%), 6.8 (55.3%), and 157.0 cc (94.6%), respectively. Median follow-up was 15.2 months. A decrease in SUVmax of at least 54% was associated with improved PFS (24-month PFS: 83.3% vs. 28.1%; p = 0.037) and FFDP (24- month FFDP: 100% vs. 62.4%; p < 0.001). A decrease in MTV of at least 90% was associated with improved FFDP (24-month FFDP: 100% vs. 62.4%; p < 0.001). LC was improved in sites with decreases in SUVmax of at least 71% (24-month LC: 100% vs. 72.7%; p < 0.001). Decreases of MTV by at least 90% (100% vs. 53.3%; p = 0.038) and TLG by at least 95% (100% vs. 56.3%; p = 0.067) were associated with an improved complete response rate. Conclusion: bRT led to substantial reductions in MTV, SUVmax, SUVmean, and TLG. The relative extent of these decreases correlated with improved outcomes after CAR T-cell infusion. Prospective cohorts should validate the value of interim PET following bRT for quantifying changes in disease burden and associated prognosis. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Prognostic significance of fludeoxyglucose positron emission tomography delta radiomics following bridging therapy in patients with large B-cell lymphoma undergoing CAR T-cell therapy.

Author

Ladbury, Colton, Hao, Claire, Watkins, William Tyler, Sampath, Sagus, Wong, Jeffrey, Amini, Arya, Sokolov, Karen, Jekwon Yeh, Al Feghali, Karine A., de Jong, Dorine, Maniyedath, Arjun, Shirvani, Shervin, Nikolaenko, Liana, Mei, Matthew, Herrera, Alex, Popplewell, Leslie, Budde, Lihua Elizabeth, and Dandapani, Savita

Subjects
POSITRON emission tomography, CHIMERIC antigen receptors, RADIOMICS, PROGRESSION-free survival, RADIOTHERAPY
Abstract

Purpose/objective(s): Bridging radiation therapy (bRT) is increasingly being utilized prior to chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma (LBCL). It is unknown how the extent of cytoreduction during bRT impacts outcomes. Materials/ Methods: We retrospectively reviewed patients with LBCL treated with bRT followed by CAR T-cell therapy. Metabolic tumor volume (MTV), maximum standardized uptake value (SUVmax), SUVmean, and total lesion glycolysis (TLG) were extracted from F18-fluorodeoxyglucose positron emission tomography (PET) scans acquired prior to bRT and between completion of bRT and CAR Tcell infusion. Delta radiomics based on changes of these values were then calculated. The association between delta radiomics and oncologic outcomes [progression-free survival (PFS), freedom from distant progression (FFDP), and local control (LC)] were then examined. Results: Thirty-three sites across 23 patients with LBCL were irradiated. All metabolically active disease was treated in 10 patients. Following bRT, median overall decreases (including unirradiated sites) in MTV, SUVmax, SUVmean, and TLG were 22.2 cc (63.1%), 8.9 (36.8%), 3.4 (31.1%), and 297.9 cc (75.8%), respectively. Median decreases in MTV, SUVmax, SUVmean, and TLG in irradiated sites were 15.6 cc (91.1%), 17.0 (74.6%), 6.8 (55.3%), and 157.0 cc (94.6%), respectively. Median follow-up was 15.2 months. A decrease in SUVmax of at least 54% was associated with improved PFS (24-month PFS: 83.3% vs. 28.1%; p = 0.037) and FFDP (24-month FFDP: 100% vs. 62.4%; p < 0.001). A decrease in MTV of at least 90% was associated with improved FFDP (24-month FFDP: 100% vs. 62.4%; p < 0.001). LC was improved in sites with decreases in SUVmax of at least 71% (24-month LC: 100% vs. 72.7%; p < 0.001). Decreases of MTV by at least 90% (100% vs. 53.3%; p = 0.038) and TLG by at least 95% (100% vs. 56.3%; p = 0.067) were associated with an improved complete response rate. Conclusion: bRT led to substantial reductions in MTV, SUVmax, SUVmean, and TLG. The relative extent of these decreases correlated with improved outcomes after CAR T-cell infusion. Prospective cohorts should validate the value of interim PET following bRT for quantifying changes in disease burden and associated prognosis. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study

Author

Kwak, Larry W., Sancho, Juan-Manuel, Cho, Seok-Goo, Nakazawa, Hideyuki, Suzumiya, Junji, Tumyan, Gayane, Kim, Jin Seok, Menne, Tobias, Mariz, José, Ilyin, Nikolai, Jurczak, Wojciech, Lopez Martinez, Aurelio, Samoilova, Olga, Zhavrid, Edvard, Yañez Ruiz, Eduardo, Trneny, Marek, Popplewell, Leslie, Ogura, Michinori, Kim, Won-Seog, Lee, Sang Joon, Kim, Sung Hyun, Ahn, Keum Young, and Buske, Christian

Published
2022
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21. Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author

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

Published
2022
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22. Flotetuzumab as a salvage immunotherapy in advanced CD123-positive hematological malignancies, a phase 1 pilot study

Author

Aldoss, Ibrahim, primary, Zhang, Jianying, additional, Robbins, Marjorie, additional, Song, Joo, additional, Al Malki, Monzr M., additional, Otoukesh, Salman, additional, Sandhu, Karamjeet, additional, Agrawal, Vaibhav, additional, Herrera, Alex F., additional, Popplewell, Leslie L., additional, Ghoda, Lucy, additional, Stein, Anthony, additional, Marcucci, Guido, additional, Forman, Stephen, additional, and Pullarkat, Vinod, additional

Published
2024
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25. Anti-CD25 Radioimmunotherapy with BEAM Autologous Hematopoietic Cell Transplantation Conditioning in Hodgkin Lymphoma

Author

Herrera, Alex F., Palmer, Joycelynne, Adhikarla, Vikram, Yamauchi, Dave, Poku, Erasmus K., Bading, James, Yazaki, Paul, Dandapani, Savita, Mei, Matthew, Chen, Robert, Cao, Thai, Karras, Nicole, McTague, Pamela, Nademanee, Auayporn, Popplewell, Leslie, Sahebi, Firoozeh, Shively, John E., Simpson, Jennifer, Smith, D. Lynne, Song, Joo, Spielberger, Ricardo, Tsai, Ni-Chun, Thomas, Sandra H., Forman, Stephen J., Colcher, David, Wu, Anna M., Wong, Jeffrey, and Smith, Eileen

Published
2021
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26. Real‐world experience of axicabtagene ciloleucel, a CD19‐directed CAR T‐cell therapy, in the second‐line treatment of early relapsed or primary refractory large B‐cell lymphoma.

Author

Othman, Tamer, Baird, John H., Pak, Stacy, Mei, Matthew, Herrera, Alex F., Mansour, Joshua, Shouse, Geoffrey, Sahebi, Firoozeh, Spielberger, Ricardo, Cai, Ji‐Lian, Farol, Leonardo, Godfrey, James, Kallam, Avyakta, Phillips, Tycel, Popplewell, Leslie, Siddiqi, Tanya, Forman, Stephen, and Budde, Lihua E.

Subjects
SKIN cancer, T cells, INFORMED consent (Medical law)
Abstract

This article examines the use of axicabtagene ciloleucel (axi-cel), a CAR T-cell therapy, as a second-line treatment for large B-cell lymphoma (LBCL) in a real-world setting. The study analyzes data from patients who received axi-cel at a single center and evaluates various outcomes such as survival rates, response rates, and side effects. The results indicate that axi-cel is effective and well-tolerated, providing valuable insights for its use in clinical practice. However, larger studies with longer follow-up are needed to further validate its efficacy and practicality. [Extracted from the article]

Published
2024
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27. Real-World Tisagenlecleucel Outcomes in Richter-Transformed Chronic Lymphocytic Leukemia: A Center for International Blood & Marrow Transplant Research (CIBMTR) Analysis

Author

Shadman, Mazyar, primary, Frigault, Matthew J., additional, Foley, Stephen Ronan, additional, Hill, Brian T., additional, Schofield, Grant, additional, Jacobson, Caron A., additional, Jaglowski, Samantha, additional, Locke, Frederick L., additional, Landsburg, Daniel J., additional, Ram, Ron, additional, Riedell, Peter A., additional, Shah, Gunjan L., additional, Popplewell, Leslie, additional, Tiwari, Ranjan, additional, Lim, Stephen, additional, Maier, Harald Jakob, additional, Majdan, Marta, additional, and Pasquini, Marcelo C., additional

Published
2024
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28. Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up

Author

Schuster, Stephen J., primary, Fowler, Nathan H., additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio C., additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter A., additional, Ho, P Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy I., additional, Nastoupil, Loretta J., additional, von Tresckow, Bastian, additional, Ferreri, Andres Jose Maria, additional, Teshima, Takanori, additional, Patten, Piers EM, additional, McGuirk, Joseph P., additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier Luigi, additional, Malladi, Ram, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Paule, Ines, additional, Germano, Davide, additional, Ramos, Roberto, additional, Hsu, Pei, additional, Thieblemont, Catherine, additional, and Dreyling, Martin, additional

Published
2024
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29. Durable Efficacy and Manageable Safety in Patients Age ≥75 Years with Relapsed/Refractory Large B-Cell Lymphoma Treated with Tisagenlecleucel in the Real-World Setting

Author

Landsburg, Daniel J., primary, Heim, Michael, additional, Moskop, Amy, additional, Foley, Stephen Ronan, additional, Hill, Brian T., additional, Schofield, Grant, additional, Jacobson, Caron A., additional, Jaglowski, Samantha, additional, Locke, Frederick L., additional, Ram, Ron, additional, Riedell, Peter A., additional, Shah, Gunjan L., additional, Popplewell, Leslie, additional, Tiwari, Ranjan, additional, Lim, Stephen, additional, Maier, Harald Jakob, additional, Majdan, Marta, additional, Pasquini, Marcelo C., additional, and Frigault, Matthew J., additional

Published
2024
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30. A phase I pharmacodynamic study of GTI-2040, an antisense oligonucleotide against ribonuclotide reductase, in acute leukemias: a California Cancer Consortium study

Author

Kirschbaum, Mark H, Frankel, Paul, Synold, Timothy W, Xie, Zhiliang, Yen, Yun, Popplewell, Leslie, Chen, Robert, Aljitawi, Omar, Tuscano, Joseph M, Chan, Kenneth K, and Newman, Edward M

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Digestive Diseases, Clinical Research, Clinical Trials and Supportive Activities, Orphan Drug, Liver Disease, Hematology, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Drug Monitoring, Female, Humans, Leukemia, Myeloid, Acute, Male, Middle Aged, Oligodeoxyribonucleotides, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Ribonucleotide Reductases, Treatment Outcome, Acute leukemia, GTI-2040, intermittent infusion, phase I trial, pharmacodynamics, pharmacokinetics, ribonucleotide reductase, Immunology, Cardiovascular medicine and haematology
Abstract

We performed a phase I study of GTI-2040, an antisense oligonucleotide against ribonucleotide reductase mRNA, on a novel dosing schedule of days 1-4 and 15-18 by continuous infusion to examine efficacy and tolerability in patients with leukemia. A dose of 11 mg/kg/d was safely reached. Dose-limiting toxicities (DLTs) at the higher levels included elevated troponin I and liver function enzymes. There were no objective responses to GTI-2040 in this study; 7/24 patients were able to complete the predetermined three infusion cycles. Pharmacokinetic and pharmacodynamic studies were performed, indicating a trend towards increasing intracellular drug levels and decreasing RRM2 gene expression with increasing doses. This dose schedule may be considered if appropriate combinations are identified in preclinical studies.

Published
2016

32. Gene therapy: charting a future course--summary of a National Institutes of Health Workshop, April 12, 2013.

Author

O'Reilly, Marina, Federoff, Howard J, Fong, Yuman, Kohn, Donald B, Patterson, Amy P, Ahmed, Nabil, Asokan, Aravind, Boye, Shannon E, Crystal, Ronald G, De Oliveira, Satiro, Gargiulo, Linda, Harper, Scott Q, Ikeda, Yasuhiro, Jambou, Robert, Montgomery, Maureen, Prograis, Lawrence, Rosenthal, Eugene, Sterman, Daniel H, Vandenberghe, Luk H, Zoloth, Laurie, Abedi, Mehrdad, Adair, Jennifer, Adusumilli, Prasad S, Goins, William F, Gray, Jhanelle, Monahan, Paul, Popplewell, Leslie, Sena-Esteves, Miguel, Tannous, Bakhos, Weber, Thomas, Wierda, William, Gopal-Srivastava, Rashmi, McDonald, Cheryl L, Rosenblum, Daniel, and Corrigan-Curay, Jacqueline

Subjects
Animals, Education, Continuing, Genetic Research, Genetic Therapy: economics, ethics, legislation & jurisprudence, Genetic Vectors, Humans, National Institutes of Health (U.S.), Stem Cell Research, Stem Cell Transplantation, Transduction, Genetic, United States
Abstract

Recently, the gene therapy field has begun to experience clinical successes in a number of different diseases using various approaches and vectors. The workshop Gene Therapy: Charting a Future Course, sponsored by the National Institutes of Health (NIH) Office of Biotechnology Activities, brought together early and mid-career researchers to discuss the key scientific challenges and opportunities, ethical and communication issues, and NIH and foundation resources available to facilitate further clinical advances.

Published
2014

33. Phase II Study of the Oral MEK Inhibitor Selumetinib in Advanced Acute Myelogenous Leukemia: A University of Chicago Phase II Consortium Trial

Author

Jain, Nitin, Curran, Emily, Iyengar, Neil M, Diaz-Flores, Ernesto, Kunnavakkam, Rangesh, Popplewell, Leslie, Kirschbaum, Mark H, Karrison, Theodore, Erba, Harry P, Green, Margaret, Poire, Xavier, Koval, Greg, Shannon, Kevin, Reddy, Poluru L, Joseph, Loren, Atallah, Ehab L, Dy, Philip, Thomas, Sachdev P, Smith, Scott E, Doyle, L Austin, Stadler, Walter M, Larson, Richard A, Stock, Wendy, and Odenike, Olatoyosi

Subjects
Hematology, Cancer, Rare Diseases, Genetics, Childhood Leukemia, Clinical Research, Pediatric Cancer, Pediatric, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Benzimidazoles, Female, Genes, ras, Humans, Leukemia, Myeloid, Acute, Male, Middle Aged, Mitogen-Activated Protein Kinase Kinases, Mutation, Protein Kinase Inhibitors, Proto-Oncogene Proteins c-kit, Treatment Outcome, fms-Like Tyrosine Kinase 3, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeThe clinical relevance of targeting the RAS/RAF/MEK/ERK pathway, activated in 70% to 80% of patients with acute myelogenous leukemia (AML), is unknown.Experimental designSelumetinib is an oral small-molecule inhibitor of MAP-ERK kinase (MEK)-1/2. Forty-seven patients with relapsed/refractory AML or 60 years old or more with untreated AML were enrolled on a phase II study. Patients were stratified by FLT3 ITD mutation status. The primary endpoint was response rate (complete, partial, and minor). Leukemia cells were analyzed for extracellular signal-regulated kinase (ERK) and mTOR phosphorylation.ResultsCommon drug-related toxicities were grade 1-2 diarrhea, fatigue, nausea, vomiting, and skin rash. In the FLT3 wild-type cohort, six of 36 (17%) patients had a response [one partial response, three minor responses, two unconfirmed minor responses (uMR)]. No patient with FLT3 ITD responded. NRAS and KRAS mutations were detected in 7% and 2% of patients, respectively. The sole patient with KRAS mutation had uMR with hematologic improvement in platelets. Baseline p-ERK activation was observed in 85% of patients analyzed but did not correlate with a response. A single-nucleotide polymorphism (SNP) rs3733542 in exon 18 of the KIT gene was detected in significantly higher number of patients with response/stable disease compared with nonresponders (60% vs. 23%; P = 0.027).ConclusionsSelumetinib is associated with modest single-agent antileukemic activity in advanced AML. However, given its favorable toxicity profile, combination with drugs that target other signaling pathways in AML should be considered. The potential association of SNP rs3733542 in exon 18 of the KIT gene with antileukemic activity of selumetinib is intriguing, but will require validation in larger trials.

Published
2014

34. Bendamustine lymphodepletion is a well‐tolerated alternative to fludarabine and cyclophosphamide lymphodepletion for axicabtagene ciloleucel therapy for aggressive B‐cell lymphoma

Author

Ong, Shin Yeu, primary, Pak, Stacy, additional, Mei, Matthew, additional, Wang, Yan, additional, Popplewell, Leslie, additional, Baird, John H., additional, Herrera, Alex F., additional, Shouse, Geoffrey, additional, Nikolaenko, Liana, additional, Zain, Jasmine, additional, Godfrey, James, additional, Htut, Myo, additional, Aribi, Ahmed, additional, Spielberger, Ricardo, additional, Mansour, Joshua, additional, Forman, Stephen J., additional, Palmer, Joycelynne, additional, and Budde, Lihua E., additional

Published
2023
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35. POSTER: CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)

Author

Fowler, Nathan, primary, Dreyling, Martin, additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio, additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter, additional, Ho, P. Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy, additional, Nastoupil, Loretta, additional, Tresckow, Bastian von, additional, Ferreri, Andrés José María, additional, Teshima, Takanori, additional, Patten, Piers, additional, McGuirk, Joseph, additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier, additional, Malladi, Ram, additional, Paule, Ines, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Han, Xia, additional, Germano, Davide, additional, O'Donovan, Darragh, additional, Ramos, Roberto, additional, Masood, Aisha, additional, Thieblemont, Catherine, additional, and Schuster, Stephen, additional

Published
2023
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36. CT-564 ELARA Trial Update: Long-Term Clinical Outcomes and Correlative Efficacy Analyses of Tisagenlecleucel in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL)

Author

Fowler, Nathan, primary, Dreyling, Martin, additional, Dickinson, Michael, additional, Martinez-Lopez, Joaquin, additional, Kolstad, Arne, additional, Butler, Jason, additional, Ghosh, Monalisa, additional, Popplewell, Leslie, additional, Chavez, Julio, additional, Bachy, Emmanuel, additional, Kato, Koji, additional, Harigae, Hideo, additional, Kersten, Marie José, additional, Andreadis, Charalambos, additional, Riedell, Peter, additional, Ho, P. Joy, additional, Pérez-Simón, José Antonio, additional, Chen, Andy, additional, Nastoupil, Loretta, additional, Tresckow, Bastian von, additional, Ferreri, Andrés José María, additional, Teshima, Takanori, additional, Patten, Piers, additional, McGuirk, Joseph, additional, Petzer, Andreas, additional, Offner, Fritz, additional, Viardot, Andreas, additional, Zinzani, Pier, additional, Malladi, Ram, additional, Paule, Ines, additional, Zia, Aiesha, additional, Awasthi, Rakesh, additional, Han, Xia, additional, Germano, Davide, additional, O'Donovan, Darragh, additional, Ramos, Roberto, additional, Masood, Aisha, additional, Thieblemont, Catherine, additional, and Schuster, Stephen, additional

Published
2023
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40. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

Author

Ogura, Michinori, Sancho, Juan Manuel, Cho, Seok-Goo, Nakazawa, Hideyuki, Suzumiya, Junji, Tumyan, Gayane, Kim, Jin Seok, Lennard, Anne, Mariz, José, Ilyin, Nikolai, Jurczak, Wojciech, Lopez Martinez, Aurelio, Samoilova, Olga, Zhavrid, Edvard, Yañez Ruiz, Eduardo, Trneny, Marek, Popplewell, Leslie, Coiffier, Bertrand, Buske, Christian, Kim, Won-Seog, Lee, Sang Joon, Lee, Sung Young, Bae, Yun Ju, and Kwak, Larry W

Published
2018
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42. Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703)

Author

Smith, Eileen P., Li, Hongli, Friedberg, Jonathan W., Constine, Louis S., Rimsza, Lisa M., Cook, James R., Laport, Ginna G., Popplewell, Leslie L., Holmberg, Leona A., Smith, Sonali M., LeBlanc, Michael, Forman, Stephen J., Fisher, Richard I., and Stiff, Patrick J.

Published
2018
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43. Outcomes after Allogeneic Stem Cell Transplantation in Patients with Double-Hit and Double-Expressor Lymphoma

Author

Herrera, Alex F., Rodig, Scott J., Song, Joo Y., Kim, Young, Griffin, Gabriel K., Yang, Dongyun, Nikolaenko, Liana, Mei, Matthew, Bedell, Victoria, Dal Cin, Paola, Pak, Christine, Alyea, Edwin P., Budde, Lihua E., Chen, Robert, Chen, Yi-Bin, Chan, Wing C., Cutler, Corey S., Ho, Vincent T., Koreth, John, Krishnan, Amrita, Murata-Collins, Joyce L., Nikiforow, Sarah, Palmer, Joycelynne, Pihan, German A., Pillai, Raju, Popplewell, Leslie, Rosen, Steven T., Siddiqi, Tanya, Sohani, Aliyah R., Zain, Jasmine, Kwak, Larry W., Weisenburger, Dennis D., Weinstock, David M., Soiffer, Robert J., Antin, Joseph H., Forman, Stephen J., Nademanee, Auayporn P., and Armand, Philippe

Published
2018
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44. S223: REAL-WORLD EARLY OUTCOMES OF AXICABTAGENE CILOLEUCEL FOR RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA

Author

Jacobson, Caron, primary, Hemmer, Michael T., additional, Hu, Zhen-Huan, additional, Frank, Matthew, additional, Popplewell, Leslie, additional, Ahmed, Nausheen, additional, Lin, Yi, additional, Best, Timothy, additional, Beygi, Sara, additional, Miao, Harry, additional, Fu, Christine, additional, Sun, Fang, additional, Xu, Hairong, additional, and Pasquini, Marcelo, additional

Published
2023
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45. “Democratizing” cancer care: City of Hope’s national enterprise model for delivering cancer care.

Author

Schriber, Jeffrey, primary, Artz, Andrew S., additional, Purvis, Amy, additional, Slack, James L., additional, Larsen, Jeremy Todd, additional, Park, Soyoung, additional, Tulipana, Kevin Frank, additional, Majkowski, Gemini, additional, Nakamura, Ryotaro, additional, Popplewell, Leslie, additional, Herrera, Alex Francisco, additional, Budde, Lihua Elizabeth, additional, Koller, Paul B., additional, Janakiram, Murali, additional, Ball, Brian, additional, Phillips, Tycel Jovelle, additional, Rosenzweig, Michael Alan, additional, Marcucci, Guido, additional, Smith, Eileen P., additional, and Stewart, Forrest, additional

Published
2023
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46. P1125: DURABLES RESPONSES ACHIEVED WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF AUTOLOGOUS CAR T-NAÏVE PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL)

Author

Munoz, Javier, primary, Locke, Frederick, additional, Lekakis, Lazaros, additional, Eradat, Herbert, additional, Tees, Michael, additional, de Vos, Sven, additional, Nath, Rajneesh, additional, Stevens, Don, additional, Malik, Shahbaz, additional, Popplewell, Leslie, additional, Hamadani, Mehdi, additional, Oluwole, Olalekan, additional, Perales, Miguel-Angel, additional, Miklos, David, additional, Fisher, Paul, additional, Goyal, Lovely, additional, Navale, Lynn, additional, Kaufman, Gregory, additional, Kai, Kazuharu, additional, Balakumaran, Arun, additional, and Neelapu, Sattva, additional

Published
2023
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47. Results from a phase I trial of pembrolizumab plus vorinostat in relapsed/refractory B-cell non-Hodgkin lymphoma

Author

Godfrey, James, primary, Mei, Matthew, additional, Chen, Lu, additional, Song, Joo Y., additional, Bedell, Victoria, additional, Budde, Elizabeth, additional, Armenian, Saro, additional, Puverel, Sandrine, additional, Nikolaenko, Liana, additional, Chen, Robert, additional, Daniels, Shari, additional, Kennedy, Neena, additional, Peters, Lacolle, additional, Rosen, Steven T., additional, Forman, Stephen J., additional, Popplewell, Leslie L., additional, Kwak, Larry W., additional, and Herrera, Alex F., additional

Published
2023
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48. Long-Term Results of High-Dose Therapy and Autologous Stem Cell Transplantation for Mantle Cell Lymphoma: Effectiveness of Maintenance Rituximab

Author

Mei, Matthew G., Cao, Thai M., Chen, Lu, Song, Joo Y., Siddiqi, Tanya, Cai, Ji-Lian, Farol, Leonardo T., Al Malki, Monzr M., Salhotra, Amandeep, Aldoss, Ibrahim, Palmer, Joycelynne, Herrera, Alex F., Zain, Jasmine, Popplewell, Leslie L., Chen, Robert W., Rosen, Steven T., Forman, Stephen J., Kwak, Larry, Nademanee, Auayporn P., and Budde, Lihua E.

Published
2017
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50. A phase 1 first‐in‐human study of GS‐0189, an anti‐signal regulatory protein alpha (SIRPα) monoclonal antibody, in patients with relapsed/refractory (R/R) non‐Hodgkin lymphoma (NHL)

Author

Narkhede, Mayur, primary, Bartlett, Nancy L., additional, Ibrahimi, Sami, additional, Popplewell, Leslie, additional, Seto, Anna, additional, Bates, Jamie, additional, Lee, Yeonju, additional, Ganti, Vaishnavi, additional, Han, Ling, additional, Chen, Tianling, additional, and Patel, Manish R., additional

Published
2023
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