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1. Efficacy of front-line ibrutinib versus fludarabine, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia: A retrospective multicenter “Real-World” study

Author

Levi, S., Bronstein, Y., Goldschmidt, N., Morabito, Francesco, Ziv-Baran, T., Del Poeta, G., Bairey, O., Del Principe, M. I., Fineman, R., Mauro, F. R., Gutwein, O., Reda, G., Ruchlemer, R., Sportoletti, P., Laurenti, Luca, Shvidel, L., Coscia, M., Tadmor, T., Varettoni, M., Aviv, A., Murru, R., Braester, A., Chiarenza, A., Visentin, A., Pietrasanta, D., Loseto, G., Zucchetto, A., Bomben, R., Olivieri, J., Neri, A., Rossi, Dario, Gaidano, G., Trentin, L., Foa, Robin, Cuneo, A., Perry, C., Gattei, V., Gentile, M., Herishanu, Y., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi D., Foa R., Levi, S., Bronstein, Y., Goldschmidt, N., Morabito, Francesco, Ziv-Baran, T., Del Poeta, G., Bairey, O., Del Principe, M. I., Fineman, R., Mauro, F. R., Gutwein, O., Reda, G., Ruchlemer, R., Sportoletti, P., Laurenti, Luca, Shvidel, L., Coscia, M., Tadmor, T., Varettoni, M., Aviv, A., Murru, R., Braester, A., Chiarenza, A., Visentin, A., Pietrasanta, D., Loseto, G., Zucchetto, A., Bomben, R., Olivieri, J., Neri, A., Rossi, Dario, Gaidano, G., Trentin, L., Foa, Robin, Cuneo, A., Perry, C., Gattei, V., Gentile, M., Herishanu, Y., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi D., and Foa R.

Abstract

NA

Published
2023

3. Primary lymphoma of the female genital tract: a retrospective survey of the International Extranodal Lymphoma Study Group (IELSG35)

Author

Steffanoni, S., primary, Vanazzi, A., additional, Esposito, F., additional, Cabrera, M. E., additional, Akhtar, S. S., additional, Gardella, S., additional, Bairey, O., additional, Pavlovsky, A., additional, Polino, A., additional, Landi, F., additional, Stathis, A., additional, Zucca, E., additional, and Pirosa, M. C., additional

Published
2023
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4. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)—a systematic review and individual patient data meta-analysis

Author

Kasenda, B., Ferreri, A.J.M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J.Y., Hoang-Xuan, K., Pulczynski, E.J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B.P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T.T., Illerhaus, G., and Briel, M.

Published
2015
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5. Results from the international, randomized phase 3 study of ibrutinib versus chlorambucil in patients 65 Years and older with treatmentnaïve (TN) CLL/SLL (RESONATE-2TM): 4

Author

Hillmen, P, Tedeschi, A, Barr, P M, Robak, T, Owen, C, Ghia, P, Bairey, O, Bartlett, N L, Li, J, Simpson, D, Grosicki, S, Devereux, S, McCarthy, H, Coutre, S, Quach, H, Gaidano, G, Maslyak, Z, Stevens, D A, Janssens, A, Offner, F, Mayer, J, OʼDwyer, M, Hellmann, A, Schuh, A, Siddiqi, T, Pollack, A, Tam, C S, Suri, D, Zhou, C, Clow, F, Styles, L, James, D F, Kipps, T J, and Burger, J A

Published
2016

6. FIRST‐LINE TREATMENT WITH IBRUTINIB FOR PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): 7‐YEAR RESULTS FROM RESONATE‐2

Author

Coutre, S. E., primary, Barr, P. M., additional, Owen, C., additional, Robak, T., additional, Tedeschi, A., additional, Bairey, O., additional, Burger, J. A., additional, Hillmen, P., additional, Devereux, S., additional, Grosicki, S., additional, McCarthy, H., additional, Li, J., additional, Simpson, D., additional, Offner, F., additional, Moreno, C., additional, Dai, S., additional, Szoke, A., additional, Dean, J. P., additional, Kipps, T. J., additional, and Ghia, P., additional

Published
2021
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9. Frontline treatment with the combination obinutuzumab±chlorambucil for chronic lymphocytic leukemia outside clinical trials: results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Herishanu Y, Shaulov A, Fineman R, BasiC-Kinda S, Aviv A, Wasik-Szczepanek E, Jaksic O, Zdrenghea M, Greenbaum U, Mandac I, Simkovic M, Morawska M, Benjamini O, Spacek M, Nemets A, Bairey O, Trentin L, Ruchlemer R, Laurenti L, Ciocan O, Doubek M, Shvidel L, Dali N, Miras F, De Meuter A, Dimou M, Mauro F, Coscia M, Bumbea H, Szasz R, Tadmor T, Gutwein O, Gentile M, Scarfo L, Tedeschi A, Sportoletti P, Vazquez E, Marquet J, Assouline S, Papaioannou M, Braester A, Levato L, Gregor M, Rigolin G, Loscertales J, Perez A, Nijziel M, Popov V, Collado R, Slavutsky I, Itchaki G, Ringelstein S, Goldschmidt N, Perry C, Levi S, Polliack A, and Ghia P

Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O±Clb in unfit patients with CLL, in a "real-world" setting. Patients with documented del(17p13.1)/TP53mutation were excluded. A total of 437 patients (median age, 75.9years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min)were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95%CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del(11q22.3) and/or IGHV-unmutated], lymph nodes of diameter >5cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a "real-world" setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del(11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease. This article is protected by copyright. All rights reserved.

Published
2020

11. A cross-trial comparison of single-agent ibrutinib versus chlorambucil-obinutuzumab in previously untreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

Author

Tedeschi, A, Greil, R, Demirkan, F, Robak, T, Moreno, C, Barr, PM, Anz, B, Simpson, D, Gaidano, G, Bairey, O, Stevens, D, Gill, D, Flinn, IW, Kipps, TJ, Burger, JA, Lin, J, Webb, T, Fedorov, V, Styles, L, Gribben, JG, Tedeschi, A, Greil, R, Demirkan, F, Robak, T, Moreno, C, Barr, PM, Anz, B, Simpson, D, Gaidano, G, Bairey, O, Stevens, D, Gill, D, Flinn, IW, Kipps, TJ, Burger, JA, Lin, J, Webb, T, Fedorov, V, Styles, L, and Gribben, JG

Published
2020

12. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., and Tedeschi A.

Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.

Published
2020

19. S107 FIVE-YEAR FOLLOW-UP OF PATIENTS RECEIVING IBRUTINIB FOR FIRST-LINE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Author

Tedeschi, A., primary, Burger, J., additional, Barr, P.M., additional, Robak, T., additional, Owen, C., additional, Ghia, P., additional, Bairey, O., additional, Hillmen, P., additional, Coutre, S., additional, Devereux, S., additional, Grosicki, S., additional, McCarthy, H., additional, Li, J., additional, Simpson, D., additional, Offner, F., additional, Moreno, C., additional, Dai, S., additional, Lal, I., additional, Dean, J.P., additional, and Kipps, T.J., additional

Published
2019
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20. FIVE-YEAR FOLLOW-UP OF FIRST-LINE IBRUTINIB FOR TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA//SMALL LYMPHOCYTIC LYMPHOMA

Author

Tedeschi, A., primary, Burger, J., additional, Barr, P.M., additional, Robak, T., additional, Owen, C., additional, Ghia, P., additional, Bairey, O., additional, Hillmen, P., additional, Coutre, S., additional, Devereux, S., additional, Grosicki, S., additional, McCarthy, H., additional, Li, J., additional, Simpson, D., additional, Offner, F., additional, Moreno, C., additional, Dai, S., additional, Lal, I., additional, Dean, J.P., additional, and Kipps, T.J., additional

Published
2019
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21. PROSPECTIVE MULTICENTER REGISTRY FOR SECONDARY CNS INVOLVEMENT IN MALIGNANT LYMPHOMA: AN UPDATE WITH DATA FROM 181 PATIENTS

Author

Lammer, F., primary, May, L., additional, Martus, P., additional, Schroers, R., additional, Schlegel, U., additional, Hofer, S., additional, Bairey, O., additional, Schmitz, N., additional, Griesinger, F., additional, Schmidt-Hieber, M., additional, Weißinger, F., additional, Reimer, P., additional, le Coutre, P., additional, Fix, P., additional, Hopfer, O., additional, Junghanß, C., additional, Höffkes, H., additional, Heilmeier, B., additional, Möhle, R., additional, Lange, E., additional, Korfel, A., additional, and Keller, U., additional

Published
2019
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23. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia

Author

WEINKOVE, Robert, PRISTUPA, Alexander, KASYCH, Muzhdaba, YAGCI, Munci, MARCO, Jose Antonio Garcia, Vural, Filiz, Kaynar, Leylagül, BURGER, J. A., ROBAK, T., TEDESCHI, A., Barr, P. M., Owen, C., GHIA, P., Bairey, O., HILLMEN, P., BARTLETT, N. L., LI, J., SIMPSON, D., GROSICKI, S., HAMBLIN, Michael, ATKINS, James, BARRIENTOS, Jaqueline, DUNCOMBE, Andrew, GASIC, Slavisa, HOU, Jing-Zhou, KINGSLEY, Edwin, SHADMAN, Mazyar, BADOUX, Xavier, GILL, Devinder, OPAT, Stephen, BRON, Dominique, VAN DEN NESTE, Eric, JING, Hongmei, ZHU, Jun, VANDENBERGHE, Elisabeth, TADMOR, Tamar, CORTELEZZI, Agostino, GANLY, Peter, PLUTA, Andrzej, DEVEREUX, S., MCCARTHY, H., COUTRE, S., QUACH, H., GAIDANO, G., MASLYAK, Z., STEVENS, D. A., JANSSENS, A., OFFNER, F., MAYER, J., O'DWYER, M., HELLMANN, A., Schuh, A., SIDDIQI, T., POLLIACK, A., TAM, C. S., SURI, D., CHENG, M., CLOW, F., STYLES, L., JAMES, D. F., KIPPS, T. J., TIRUMALI, Nagendra, QUACKENBUSH, Robert, FEGAN, Christopher, KEATING, Michael, JEN, Jie, JINDRA, Pavel, SIMKOVIC, Martin, BRAESTER, Andrei, RUCHLEMER, Rosa, FOA, Roberto, SEMENZATO, Gianpietro, HAWKINS, Timothy, ATANASIO, Carolina Moreno, Demirkan, Fatih, PYLYPENKO, Halyna, FOX, Christopher, THIRMAN, Michael, CAMPBELL, Philip, COUGHLIN, Paul, HARRUP, Rosemary, KUSS, Bryone, TURNER, Paul, WU, Ka Lung, LARRATT, Loree, FINEMAN, Riva, MARASCA, Roberto, ZINZANI, Pier Luigi, CORBETT, Gillian, ABRISQUETA, Pau, DELGADO, Julio, GONZALEZ-BARCA, Eva, DE OTEYZA, Jaime Perez, ARSLAND, Onder, KAPLAN, Polina, OLIYNYK, Hanna, Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Robak, Tadeusz, Owen, Carolyn, Ghia, Paolo, Bairey, Osnat, Hillmen, Peter, Bartlett, Nancy L, Li, Jianyong, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, Mccarthy, Helen, Coutre, Steven, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Janssens, Ann, Offner, Fritz, Mayer, Jiří, O'Dwyer, Michael, Hellmann, Andrzej, Schuh, Anna, Siddiqi, Tanya, Polliack, Aaron, Tam, Constantine S, Suri, Deepali, Cheng, Mei, Clow, Fong, Styles, Lori, James, Danelle F, Kipps, Thomas J, M.D., Ph.D., for the RESONATE-2 Investigators [.., Pier Luigi Zinzani, Antonietta Tedeschi, ], Burger, Ja, Tedeschi, A, Barr, Pm, Robak, T, Owen, C, Ghia, P, Bairey, O, Hillmen, P, Bartlett, Nl, Li, J, Simpson, D, Grosicki, S, Devereux, S, Mccarthy, H, Coutre, S, Quach, H, Gaidano, G, Maslyak, Z, Stevens, Da, Janssens, A, Offner, F, Mayer, J, O'Dwyer, M, Hellmann, A, Schuh, A, Siddiqi, T, Polliack, A, Tam, C, Suri, D, Cheng, M, Clow, F, Styles, L, James, Df, Kipps, Tj, and for the RESONATE-2, Investigators

Subjects
Male, pci-32765, previously untreated patients, Lymphoma, Gastroenterology, Medical and Health Sciences, Medicaments antineoplàstics, Antineoplastic Agent, chemistry.chemical_compound, 0302 clinical medicine, chlorambucil, Piperidines, Obinutuzumab, immune system diseases, hemic and lymphatic diseases, Antineoplastic agents, Chronic, Fatigue, Cancer, cll, 0303 health sciences, Leukemia, Medicine (all), Hazard ratio, tyrosine kinase, Leucèmia, General Medicine, Hematology, Duvelisib, Lymphocytic, 3. Good health, Fludarabine, Aged, Antineoplastic Agents, Chlorambucil, Diarrhea, Disease-Free Survival, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Neutropenia, Pyrazoles, Pyrimidines, Survival Analysis, 030220 oncology & carcinogenesis, Ibrutinib, 6.1 Pharmaceuticals, RESONATE-2 Investigators, Acalabrutinib, medicine.drug, Human, medicine.medical_specialty, Cèl·lules B, Clinical Trials and Supportive Activities, open-label, 03 medical and health sciences, Rare Diseases, Clinical Research, Internal medicine, General & Internal Medicine, medicine, cancer, Survival rate, 030304 developmental biology, B cells, business.industry, Adenine, B-Cell, fludarabine, Evaluation of treatments and therapeutic interventions, phase-3 trial, Pirimidines, Orphan Drug, chemistry, Pyrimidine, Immunology, Pyrazole, cyclophosphamide, business
Abstract

Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. Background Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. METHODS We randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS The median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P

Published
2015

24. Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naive patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies

Author

Robak, T, Burger, JA, Tedeschi, A, Barr, PM, Owen, C, Bairey, O, Hillmen, P, Simpson, D, Grosicki, S, Devereux, S, McCarthy, H, Coutre, SE, Quach, H, Gaidano, G, Maslyak, Z, Stevens, DA, Moreno, C, Gill, DS, Flinn, IW, Gribben, JG, Mokatrin, A, Cheng, M, Styles, L, James, DF, Kipps, TJ, Ghia, P, Robak, T, Burger, JA, Tedeschi, A, Barr, PM, Owen, C, Bairey, O, Hillmen, P, Simpson, D, Grosicki, S, Devereux, S, McCarthy, H, Coutre, SE, Quach, H, Gaidano, G, Maslyak, Z, Stevens, DA, Moreno, C, Gill, DS, Flinn, IW, Gribben, JG, Mokatrin, A, Cheng, M, Styles, L, James, DF, Kipps, TJ, and Ghia, P

Abstract

Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings.

Published
2018

25. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS) : a randomised, double-blind, phase 3 study

Author

Chanan-Khan, Asher, Cramer, Paula, Demirkan, Fatih, Fraser, Graeme, Silva, Rodrigo Santucci, Grosicki, Sebastian, Pristupa, Aleksander, Janssens, Ann, Mayer, Jiri, Bartlett, Nancy L, Dilhuydy, Marie-Sarah, Pylypenko, Halyna, Loscertales, Javier, Avigdor, Abraham, Rule, Simon, Villa, Diego, Samoilova, Olga, Panagiotidis, Panagiots, Goy, Andre, Mato, Anthony, Pavlovsky, Miguel A, Karlsson, Claes, Mahler, Michelle, Salman, Mariya, Sun, Steven, Phelps, Charles, Balasubramanian, Sriram, Howes, Angela, Hallek, Michael, Assouline, S, Bence-Bruckler, I, Buckstein, R, Fraser, G, Larratt, L, Minuk, L, Villa, D, Angevine, A, Bartlett, N, Bixby, D, Caimi, P, Chanan-Khan, A, Craig, M, Forero-Torres, A, Ganguly, S, Goy, A, Heffner, L, Hermann, R, Lansigan, F, Leis, J, Letzer, J, Link, B, Liu, D, McCaul, K, McGuire, E, Skinner, W, Starodub, A, Stuart, R, Thirman, M, Tirumali, N, Yang, J, Janssens, A, Offner, F, Van den Neste, E, Van Hoof, A, Mayer, J, Novak, J, Trneny, M, Cartron, G, Dartigeas, C, Dilhuydy, M, Ghez, D, Haioun, C, Leblond, V, Salles, G, Balser, C, Cramer, P, Dreger, P, Durig, J, Eckart, M, Heinrich, B, Illmer, T, Jentsch-Ullrich, K, Pfreundschuh, M, Schetelig, J, Schlag, R, Soling, U, Stilgenbauer, S, Anagnostopoulos, A, Dimopoulos, A, Panagiotidis, P, Vrakidou, E, Bairey, O, Yehuda, D Ben, Braester, A, Fineman, R, Herishanu, Y, Nagler, A, Ruchlemer, R, Tadmor, T, Grosicki, S, Homenda, W, Jurczak, W, Pluta, A, Woszczyk, D, Espirito Santo, A, Luis, R, Raposo, J, Viveiros, C, Alexeeva, J, Dunaev, Y, Golubeva, M, Khuageva, N, Loginov, A, Lysenko, I, Osmanov, E, Pavlov, V, Pristupa, A, Proydakov, A, Rossiev, V, Samarina, I, Samoilova, O, Serduk, O, Shneider, T, Udovitsa, D, Voloshin, S, Gayoso, J, Gonzalez, M, Gonzalez Barca, E, Hernandez Rivas, J, Jargue, I, Loscertales, J, Karlsson, C, Sender, M, Aktan, M, Arslan, O, Demirkan, F, Ferhanoglu, B, Kaynar, L, Sayinalp, N, Vaural, F, Yagci, M, Dyagil, I, Kaplan, P, Masliak, Z, Oliynyk, H, Popovska, T, Pylypenko, H, Rekhtman, G, Dearden, C, Morley, N, Moss, P, Rule, S, Pavlovsky, M, Riveros, D, Santucci-Silva, R, Romeo, M, Scheliga, A, Salazar, L, Gomez, D, Ramirez, E, and Jung, C

Subjects
Male, Medizin, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, immune system diseases, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Atrial Fibrillation, Bendamustine Hydrochloride, Aged, 80 and over, Anemia, Nausea, Middle Aged, 3. Good health, Fludarabine, Intention to Treat Analysis, Oncology, 030220 oncology & carcinogenesis, Ibrutinib, Retreatment, Disease Progression, Rituximab, Female, medicine.drug, Bendamustine, Adult, medicine.medical_specialty, Neutropenia, Hemorrhage, Disease-Free Survival, 03 medical and health sciences, Double-Blind Method, Internal medicine, medicine, Humans, Aged, Performance status, business.industry, Adenine, medicine.disease, Interim analysis, Leukemia, Lymphocytic, Chronic, B-Cell, Thrombocytopenia, Surgery, Regimen, Pyrimidines, chemistry, Pyrazoles, Mantle cell lymphoma, business, 030215 immunology
Abstract

Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma.The HELIOS trial was an international, double-blind, placebo-controlled, phase 3 study in adult patients (≥18 years of age) who had active chronic lymphocytic leukaemia or small lymphocytic lymphoma with measurable lymph node disease (1·5 cm) by CT scan, and had relapsed or refractory disease following one or more previous lines of systemic therapy consisting of at least two cycles of a chemotherapy-containing regimen, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow, liver, and kidney function. Patients with del(17p) were excluded because of known poor response to bendamustine plus rituximab. Patients who had received previous treatment with ibrutinib or other BTK inhibitors, refractory disease or relapse within 24 months with a previous bendamustine-containing regimen, or haemopoietic stem-cell transplant were also excluded. Patients were randomly assigned (1:1) by a web-based system to receive bendamustine plus rituximab given in cycles of 4 weeks' duration (bendamustine: 70 mg/m(2) intravenously on days 2-3 in cycle 1, and days 1-2 in cycles 2-6; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6 for a maximum of six cycles) with either ibrutinib (420 mg daily orally) or placebo until disease progression or unacceptable toxicity. Patients were stratified according to whether they were refractory to purine analogues and by number of previous lines of therapy. The primary endpoint was independent review committee (IRC)-assessed progression-free survival. Crossover to ibrutinib was permitted for patients in the placebo group with IRC-confirmed disease progression. Analysis was by intention-to-treat and is continuing for further long-term follow-up. The trial is registered with ClinicalTrials.gov, number NCT01611090.Between Sept 19, 2012, and Jan 21, 2014, 578 eligible patients were randomly assigned to ibrutinib or placebo in combination with bendamustine plus rituximab (289 in each group). The primary endpoint was met at the preplanned interim analysis (March 10, 2015). At a median follow-up of 17 months (IQR 13·7-20·7), progression-free survival was significantly improved in the ibrutinib group compared with the placebo group (not reached in the ibrutinib group (95% CI not evaluable) vs 13·3 months (11·3-13·9) in the placebo group (hazard ratio [HR] 0·203, 95% CI 0·150-0·276; p0·0001). IRC-assessed progression-free survival at 18 months was 79% (95% CI 73-83) in the ibrutinib group and 24% (18-31) in the placebo group (HR 0·203, 95% CI 0·150-0·276; p0·0001). The most frequent all-grade adverse events were neutropenia and nausea. 222 (77%) of 287 patients in the ibrutinib group and 212 (74%) of 287 patients in the placebo group reported grade 3-4 events; the most common grade 3-4 adverse events in both groups were neutropenia (154 [54%] in the ibrutinib group vs 145 [51%] in the placebo group) and thrombocytopenia (43 [15%] in each group). A safety profile similar to that previously reported with ibrutinib and bendamustine plus rituximab individually was noted.In patients eligible for bendamustine plus rituximab, the addition of ibrutinib to this regimen results in significant improvements in outcome with no new safety signals identified from the combination and a manageable safety profile.Janssen ResearchDevelopment.

Published
2016

28. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)—a systematic review and individual patient data meta-analysis

Author

Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., Briel, M., Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., and Briel, M.

Abstract

Evidence for prognosis and treatment of elderly patient with primary central nervous system is limited. High-dose methotrexate should be applied whenever possible, especially combination with oral alkylating agents is a promising approach. Further combinations with other intravenous drugs do not seem to improve outcome. More prospective trials designed for elderly PCNSL patients are warranted

Published
2017

29. Therapeutic role of rituximab in the treatment of intravascular large B-cell lymphoma

Author

Dognini, G. P., Ponzoni, M., Doglioni, C., Martelli, M., Ambrosetti, A., Rossi, G., Federico, M., anna candoni, Renzo, A., Bairey, O., Szomor, A., Horvath, B., Uziel, L., Seymour, J., Willemze, R., Ferreri, A. J. M., Dognini, Gp, Ponzoni, Maurilio, Doglioni, C, Martelli, M, Ambrosetti, A, Rossi, G, Federico, M, Candoni, A, De Renzo, A, Bairey, O, Szomor, A, Horvath, B, Uziel, L, Seymour, J, Willemze, R, and Ferreri, Ajm

Published
2007

30. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)-a systematic review and individual patient data meta-analysis

Author

Kasenda, B. (Benjamin), Ferreri, A.J.M. (Andrés J.M.), Marturano, E., Forst, D., Bromberg, J.E.C. (Jacoline), Ghesquieres, H., Ferlay, C., Blay, J.Y. (Jean Yves), Hoang-Xuan, K. (Khê), Pulczynski, E.J., Fosså, A., Okoshi, Y., Chiba, S. (Shigeru), Fritsch, K. (Kristina), Omuro, A., O'Neill, B.P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T.T. (Tracy), Illerhaus, G. (Gerald), Brie, M., Kasenda, B. (Benjamin), Ferreri, A.J.M. (Andrés J.M.), Marturano, E., Forst, D., Bromberg, J.E.C. (Jacoline), Ghesquieres, H., Ferlay, C., Blay, J.Y. (Jean Yves), Hoang-Xuan, K. (Khê), Pulczynski, E.J., Fosså, A., Okoshi, Y., Chiba, S. (Shigeru), Fritsch, K. (Kristina), Omuro, A., O'Neill, B.P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T.T. (Tracy), Illerhaus, G. (Gerald), and Brie, M.

Abstract

Background: To investigate prognosis and effects of first-line therapy in elderly primary central nervous system lymphoma (PCNSL) patients. Patients and methods: A systematic review of studies about first-line therapy in immunocompetent patients ≥60 years with PCNSL until 2014 and a meta-analysis of individual patient data from eligible studies and international collaborators were carried out. Results: We identified 20 eligible studies; from 13

Published
2015
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31. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia.

Author

Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., Janssens A., Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., and Janssens A.

Abstract

Summary: Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.Copyright © 2014 John Wiley & Sons Ltd.

Published
2015

32. Haemarthrosis in patients with mild coagulation factor deficiency

Author

Inbal A, Bairey O, and Shaklai M

Subjects
Adult, Male, medicine.medical_specialty, Screening test, Coagulation Factor Deficiency, Factor XI Deficiency, Hemophilia B, Severity of Illness Index, Gastroenterology, Internal medicine, Hemarthrosis, Coagulation testing, medicine, Humans, In patient, Spontaneous haemarthrosis, Factor X Deficiency, Aged, Factor IX, Routine screening, business.industry, Hematology, General Medicine, Coagulation, Female, business, medicine.drug
Abstract

While haemarthrosis is a common finding in severe factor VIII or IX deficiency, it is unusual in mild coagulation factor deficiencies. We describe three patients with mild factor IX, X or XI deficiency who presented with spontaneous haemarthrosis. All underwent joint puncture with subsequent worsening of the haemarthrosis in the affected joint. This report indicates that: (i) even mild coagulation factor deficiency may be associated with haemarthrosis; (ii) patients with suspected haemarthrosis should undergo routine screening coagulation tests before joint puncture; and (iii) any abnormalities in the screening tests indicate a need for further evaluation of the coagulation status. In such cases puncture of the joint should be deferred and specific therapy started immediately.

Published
1991
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42. Rituximab improves outcome in Western patients with intravascular large B-cell lymphoma (IVL)

Author

Dognini, G. P., Ponzoni, M., Bairey, O., Montalban, C., Szomor, A., Uziel, L., Seymour, J., Ambrosetti, A., Martelli, M., Rossi, G., Federico, M., anna candoni, Renzo, A., Piris, M., Zucca, E., Doglioni, C., Ferreri, A. J., Dognini, Gp, Ponzoni, Maurilio, Bairey, O, Montalban, C, Szomor, A, Uziel, L, Seymour, J, Ambrosetti, A, Martelli, M, Rossi, G, Federico, M, Candoni, A, De Renzo, A, Piris, M, Zucca, E, Doglioni, C, and Ferreri, Aj

44. Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia: extended phase 3 results from RESONATE-2.

Author

Barr, P.M., Robak, T., Owen, C., Tedeschi, A., Bairey, O., Bartlett, N.L., Burger, J.A., Hillmen, P., Coutre, S., Devereux, S., Grosicki, S., McCarthy, Helen, Li, J., Simpson, D., Offner, F., Moreno, C., Zhou, C., Styles, L., James, D., Kipps, T.J., Ghia, P., Barr, P.M., Robak, T., Owen, C., Tedeschi, A., Bairey, O., Bartlett, N.L., Burger, J.A., Hillmen, P., Coutre, S., Devereux, S., Grosicki, S., McCarthy, Helen, Li, J., Simpson, D., Offner, F., Moreno, C., Zhou, C., Styles, L., James, D., Kipps, T.J., and Ghia, P.

Abstract

Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic leukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. A total of 269 patients aged ≥65 years with previously untreated chronic lymphocytic leukemia without del(17p) were randomized 1:1 to ibrutinib (n=136) or chlorambucil (n=133) on days 1 and 15 of a 28-day cycle for 12 cycles. Median ibrutinib treatment duration was 28.5 months. Ibrutinib significantly prolonged progression-free survival versus chlorambucil (median, not reached vs 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; P<0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del[11q] and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years [88%], ≥75 years [89%]). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib versus chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at clinicaltrials.gov identifier 01722487 and 01724346.

45. First-line treatment and outcome of elderly patients with primary central nervous system lymphoma (PCNSL)—a systematic review and individual patient data meta-analysis

Author

Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., Briel, M., Kasenda, B., Ferreri, A. J. M., Marturano, E., Forst, D., Bromberg, J., Ghesquieres, H., Ferlay, C., Blay, J. Y., Hoang-Xuan, K., Pulczynski, E. J., Fosså, A., Okoshi, Y., Chiba, S., Fritsch, K., Omuro, A., O'Neill, B. P., Bairey, O., Schandelmaier, S., Gloy, V., Bhatnagar, N., Haug, S., Rahner, S., Batchelor, T. T., Illerhaus, G., and Briel, M.

Abstract

Evidence for prognosis and treatment of elderly patient with primary central nervous system is limited. High-dose methotrexate should be applied whenever possible, especially combination with oral alkylating agents is a promising approach. Further combinations with other intravenous drugs do not seem to improve outcome. More prospective trials designed for elderly PCNSL patients are warranted

47. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia.

Author

Burger, J. A., Tedeschi, A., Barr, P. M., Robak, T., Owen, C., Ghia, P., Bairey, O., Hillmen, P., Bartlett, N. L., Li, J., Simpson, D., Grosicki, S., Devereux, S., McCarthy, H., Coutre, S., Quach, H., Gaidano, G., Maslyak, Z., Stevens, D. A., and Janssens, A.

Subjects
*ANTINEOPLASTIC agents, *CHRONIC lymphocytic leukemia, *CLINICAL trials, *DIARRHEA, *FATIGUE (Physiology), *HETEROCYCLIC compounds, *NEUTROPENIA, *PROGNOSIS, *RESEARCH funding, *STATISTICAL sampling, *SURVIVAL analysis (Biometry), *RANDOMIZED controlled trials, *CHLORAMBUCIL, *THERAPEUTICS
Abstract

Background: Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma.Methods: We randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee.Results: The median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P<0.001). Ibrutinib significantly prolonged overall survival; the estimated survival rate at 24 months was 98% with ibrutinib versus 85% with chlorambucil, with a relative risk of death that was 84% lower in the ibrutinib group than in the chlorambucil group (hazard ratio, 0.16; P=0.001). The overall response rate was higher with ibrutinib than with chlorambucil (86% vs. 35%, P<0.001). The rates of sustained increases from baseline values in the hemoglobin and platelet levels were higher with ibrutinib. Adverse events of any grade that occurred in at least 20% of the patients receiving ibrutinib included diarrhea, fatigue, cough, and nausea; adverse events occurring in at least 20% of those receiving chlorambucil included nausea, fatigue, neutropenia, anemia, and vomiting. In the ibrutinib group, four patients had a grade 3 hemorrhage and one had a grade 4 hemorrhage. A total of 87% of the patients in the ibrutinib group are continuing to take ibrutinib.Conclusions: Ibrutinib was superior to chlorambucil in previously untreated patients with CLL or small lymphocytic lymphoma, as assessed by progression-free survival, overall survival, response rate, and improvement in hematologic variables. (Funded by Pharmacyclics and others; RESONATE-2 ClinicalTrials.gov number, NCT01722487.). [ABSTRACT FROM AUTHOR]

Published
2015
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48. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Rosa Ruchlemer, Angeles Medina Perez, Ariel Aviv, Alessandra Tedeschi, Sandra Bašić-Kinda, Sarit Assouline, Marta Morawska, Mihnea Zdrenghea, Maria Papaioannou, Gilad Itchaki, Viola Maria Popov, Odit Gutwein, Rosa Collado, Michael Gregor, Horia Bumbea, Inga Mandac, Livio Trentin, Neta Goldschmidt, Paolo Sportoletti, Adir Shaulov, Marta Coscia, Gian Matteo Rigolin, Anatoly Nemets, Francesca Romana Mauro, Róbert Szász, Nagib Dali, Fatima Miras, Massimo Gentile, Shimrit Ringelstein, Martin Simkovic, Martin Spacek, Uri Greenbaum, Aaron Polliack, Lydia Scarfò, Michael Doubek, Riva Fineman, Andrei Braester, Lev Shvidel, M.R. Nijziel, Irma Slavutsky, Tamar Tadmor, Eva Gimeno Vázquez, Yair Herishanu, Juan Marquet, Ozren Jakšić, Shai Levi, Ohad Benjamini, Javier Loscertales, Oana Stanca Ciocan, Paolo Ghia, Luciano Levato, Chava Perry, Maria Dimou, Anne De Meûter, Ewa Wasik-Szczepanek, Luca Laurenti, Osnat Bairey, Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, L., Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, M., Scarfo', L., Tedeschi, A., Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., and Ghia, P.

Subjects
obinutuzumab, Oncology, Male, chemistry.chemical_compound, 0302 clinical medicine, Obinutuzumab, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Chronic, Humanized, chronic lymphocytic leukemia, obinutuzumab, chlorambucil, Aged, 80 and over, Leukemia, Hematology, Lymphocytic, 3. Good health, Survival Rate, 030220 oncology & carcinogenesis, Ibrutinib, Female, Aged, Antibodies, Monoclonal, Humanized, Chlorambucil, Chromosomes, Human, Pair 17, Disease-Free Survival, Humans, Retrospective Studies, Tumor Suppressor Protein p53, Chromosome Deletion, Leukemia, Lymphocytic, Chronic, B-Cell, IGHV@, medicine.drug, Human, medicine.medical_specialty, chronic lymphocytic leukemia, chlorambucil, Antibodies, Chromosomes, NO, 03 medical and health sciences, Internal medicine, medicine, Progression-free survival, Survival rate, Venetoclax, business.industry, Pair 17, B-Cell, Clinical trial, Settore MED/15 - MALATTIE DEL SANGUE, chemistry, business, 030215 immunology
Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.

Published
2020

49. Variations in clinical presentation, frequency of hemophagocytosis and clinical behavior of intravascular lymphoma diagnosed in different geographical regions

Author

Ferreri, Andrés J. M., Dognini, Giuseppina P., Elías Campo, Rein Willemze, Seymour, John F., Osnat Bairey, Maurizio Martelli, Renz, Amalia O., Claudio Doglioni, Carlos Montalbán, Alberto Tedeschi, Astrid Pavlovsky, Sue Morgan, Lilj Uziel, Massimo Ferracci, Stefano Ascani, Umberto Gianelli, Carlo Patriarca, Fabio Facchetti, Alessio Dalla Libera, Barbara Pertoldi, Barbara Horváth, Arpad Szomor, Emanuele Zucca, Franco Cavalli, Maurilio Ponzoni, International Extranodal Lymphoma Study Group (IELSG), Translational Immunology Groningen (TRIGR), Ferreri, Ajm, Dognini, Gr, Campo, E, Willemze, R, Seymour, Jf, Bairey, O, Martelli, M, De Renzo, A, Doglioni, C, Montalan, C, Tedeschi, A, Pavlovsky, A, Morgan, S, Uziel, L, Ferracci, M, Ascani, S, Gianelli, U, Patriarca, C, Facchetti, F, Libera, Ad, Pertoldi, B, Horvath, B, Szomor, A, Zucca, E, Cavalli, F, and Ponzoni, Maurilio

Subjects
Questionnaires, Male, Pathology, Skin Neoplasms, intravascular lymphoma, Cutaneous lymphoma, Japan, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols, Anthracyclines, Aged, 80 and over, Hematology, Brain Neoplasms, Middle Aged, Prognosis, Vascular Neoplasms, Europe, Histiocytosis, Phenotype, Treatment Outcome, Organ Specificity, Disease Progression, Female, Lymphoma, Large B-Cell, Diffuse, Hemophagocytosis, brain lymphoma, cutaneous lymphoma, hemophagocytosis, Asian Continental Ancestry Group, Adult, medicine.medical_specialty, Asia, Adolescent, Anemia, European Continental Ancestry Group, Lymphohistiocytosis, Hemophagocytic, White People, Asian People, Internal medicine, medicine, Humans, Aged, Retrospective Studies, Intravascular large B-cell lymphoma, business.industry, Retrospective cohort study, medicine.disease, Lymphoma, business, Follow-Up Studies, Forecasting
Abstract

Background and Objectives This study explored variations in the clinical manifestations of intravascular lymphoma (IVL) on the bases of the association with hemophagocytosis and the country where the diagnosis was made. Design and Methods The clinical features of 50 Western patients with IVL were compared with those of 123 patients with IVL diagnosed in Eastern countries (87 diagnosed in Japan and 36 in other Asian countries), previously reported in English literature, and collected by an electronic bibliographic search. Results Hemophagocytosis was absent in Western patients, but reported in 38 (44%) Japanese patients ( p =0.00001) and in seven (19%) patients from other Asian countries ( p =0.002). No clinical differences were evident between patients with hemophagocytosis-negative IVL diagnosed in Western countries, Japan and other Asian Countries. Conversely, Japanese and non-Japanese patients with hemophagocytosis-related IVL more frequently had stage IV disease, fever, hepato-splenic involvement, marrow infiltration, dyspnea, anemia, and thrombocytopenia, and rarely exhibited cutaneous or central nervous system involvement. Lymph node and peripheral blood involvement was uncommon in all subgroups. In Western patients, anthracycline-based chemotherapy was associated with a 52% remission rate, and a 2-year overall survival of 46%. Interpretation and Conclusions The clinical features of IVL vary according to the association with hemophagocytosis, regardless of the country in which the diagnosis is made. Western, Japanese and other Asian patients with hemophagocytosis-negative IVL display similar clinical characteristics and should be considered as having classical IVL. Patients with hemophagocytosis-related IVL show significantly different clinical features. Both forms have a poor prognosis. Extensive molecular studies are needed to explore whether these clinical differences might reflect discordant biological entities within IVL.

Published
2007
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50. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Author

Awan, Farrukh T, Hillmen, Peter, Hellmann, Andrzej, Robak, Tadeusz, Hughes, Steven G., Trone, Denise, Shannon, Megan, Flinn, Ian W., Byrd, John C., Riveros, Dardo, Pavlovsky, Santiago, Iastrebner, Claudio M., Carney, Dennis A., Deveridge, Sandra, Durrant, Simon, Hahn, Uwe H., Hertzberg, Mark, Leahy, Michael F., David, Ma, Marlton, Paula, Mulligan, Stephen, Opat, Stephen S., Tiley, Campbell, Wickham, Nicholas W., Cannell, Paul, Gatalano, John, Catalano, John, Cull, Gavin, Luen B., To, Hopfinger, Georg, Jager, Ulrich, Linkesch, Werner, Petzer, Andreas, Schwarzmeier, Josef, Steurer, Michael, Greil, Richard, Bememan, Zwi, Bosly, Andre, Bron, Dominique, Janssens, Ann, Offner, Fritz, Van Den Neste, Eric W., Ka Lung, Wu, Van Hoof, Achiel, Maiolino, Angelo, Pinczowski, Helio, Zanichelli, Maria A., Pereira, Juliana, Larratt, Loree, Spaner, David, Howson Jan, Kang, Chen, Christine I., Cantin, Guy, Fernandez, Louis A., Fraser, Graeme, Mayer, Jiri, Trneny, Marek, Jebavy, Ladislav, Bordessoule, Dominique, Lamy, Thierry, Milpied, Noel, Truchan Graczyk, Malgorzata, Eghbali, Houchingue, Karsenti, Jean Michel, Celigny, Philippe Solal, Mans, Le, Cazin, Bruno, Gyan, Emmanuel, Lepretre, Stephane, Bergmann, Lothar, Tsionos, Konstantinos, Lokeshwar, Nilesh M., Agarwal, Mohan B., Ross, Cecil R., Deshmukh, Chetan D., Narayanan, Geetha, Raina, Vinod, Bondarde, Shailesh A., Shah, Bhavin A., Bairey, Osnat, Tikva, Petach, Shvidel, Lev, Ambrosetti, Achille, Rossi, Policlinico G. B., Angelucci, Emanuele, Carella, Angelo M., Massaia, Massimo, Zinzani, Pier L., Caligaris Cappio, Federico, Foa, Roberto, Gaidano, Gianluca, della Caritá, A. O. Maggiore, Leone, Giuseppe, Santoro, Armando, Griskevicius, Laimonas, Jurgutis, Romualdas, Baker, Bartrum W., Hawkins, Timothy, Corbett, Gillian M., Ganly, Peter, D'Souza, Alvyn B., Deptala, Andrzej, Holowiecki, Jerzy, Kloczko, Janusz, Skotnicki, Aleksander, Zdziarska, Barbara, Kyrcz Krzemien, Slawomira, Dmoszynska, Anna, Moreira, Anna, Pereira, Ana P., Colita, Andrei, Moicean, Andreea D., Vasilica, Mariana, Danaila, Catalin, Gheorghita, Emanuil, Pavlov, Vyacheslav V., Rossiev, Viktor A., Konstantinova, Tatiana, Samoilova, Olga S., Novgorod, Nizhniy, Shelekhova, Tatyana, Zaritsky, Andrey Y., Abdulkadyrov, Kudrat M., Zyuzgin, Ilya S., Pristupa, Alexander S., Loscertales, Javier, Vidal, Joan Besalduch, de Mallorca, Palma, Gonzalez, Marcos, Ortuno, Francisco, Giraldo, Pilar, Nathwani, Amit, Agrawal, Samir G., Rule, Simon, Dearden, Claire E., Bloor, Adrian J., Haynes, Andrew, Singer, Charles, Boclek, Robert G., Bosserman, Linda D., Chan, David, Davidson, Sheldon J., Dichmann, Robert A., Farber, Charles, Hart, Lowell, Hermann, Robert, Eddie, Hu, Janakiraman, Nalini, Jonas, William, Liem, Kiem D., Mcintyre, Rosemary E., O'Brien, Susan, Patel, Giribala, Rado, Thomas, Schilder, Russell, Smith, Scott E., Stock, Wendy, Turturro, Francesco, Venugopal, Parameswaran, Anderson, Thomas C., Berry, William, Boyd, Thomas E., Byrd, John, Cooper, Maureen, Flinn, Ian, Gersh, Robert, Gordon, David, Guzley, Gregory J., Wilks, Sharon T., Klein, Andreas, Krauss, John C., Lister, John, Mandell, Lance, Molina, Arthur, Cooper, Barry, Pendergrass, Kelly B., Reeder, Craig, Savin, Michael A., Spitzer, Gary, Tuscano, Joseph M., Vandeventer, Hendrik, Eradat, Herbert A., Masood, Aisha, Mena, Raul, F. T. Awan, P. Hillmen, A. Hellmann, T. Robak, S. G. Hughe, D. Trone, M. Shannon, I. W. Flinn, J. C. Byrd, L. U. C., and Riveros D, Iastrebner CM, Carney DA, Deveridge S, Durrant S, Hahn UH, Hertzberg M, Leahy MF, Ma D, Marlton P, Mulligan S, Opat SS, Tiley C, Wickham NW, Cannell P, Gatalano J, Cull G, B To L, Catalano J, Wickham NW, Hopfinger G, Jager U, Linkesch W, Petzer A, Schwarzmeier J, Steurer M, Greil R, Bememan Z, Bosly A, Bron D, Janssens A, Offner F, Van Den Neste EW, Wu KL, Van Hoof A, Maiolino A, Pinczowski H, Zanichelli MA, Pereira J, Larratt L, Spaner D, Howson-Jan K, Chen CI, Fernandez LA, Fraser G, Mayer J, Trneny M, Jebavy L, Bordessoule D, Lamy T, Milpied N, Eghbali H, Karsenti JM, Celigny PS, Cazin B, Gyan E, Lepretre S, Bergmann L, Tsionos K, Lokeshwar NM, Agarwal MB, Ross CR, Deshmukh CD, Narayanan G, Raina V, Bondarde SA, Shah BA, Bairey O, Ben-Yehuda D, Shvidel L, Ambrosetti A, Angelucci E, Carella AM, Massaia M, Zinzani PL, Caligaris-Cappio F, Foa R, Gaidano G, Leone G, Santoro A, Griskevicius L, Jurgutis R, Baker BW, Hawkins T, Corbett GM, Ganly P, D'Souza AB, Deptala A, Hellmann A, Holowiecki J, Kloczko J, Skotnicki A, Zdziarska B, Robak T, Dmoszynska A, Moreira I, Pereira AP, Colita A, Moicean AD, Gheorghita E, Vasilica M, Pavlov VV, Rossiev VA, Konstantinova T, Samoilova OS, Novgorod N, Shelekhova T, Zaritsky AY, Abdulkadyrov KM, Zyuzgin IS, Pristupa AS, Loscertales J, Casado LF, Gonzalez M, Ortuno F, Giraldo P, Servet M, Nathwani A, Howson-Jan K, Agrawal SG, Hillmen P, Rule S, Dearden CE, Bloor AJ, Haynes A, Singer C, Boclek RG, Bosserman LD, Chan D, Davidson SJ, Dichmann RA, Farber C, Guzley GJ, Hermann R, Hu E, Janakiraman N, Jonas W, Liem KD, Mcintyre RE, O'Brien S, Patel G, Rado T, Schilder R, Smith SE, Stock W, Turturro F, Venugopal P, Berry W, Boyd TE, Byrd J, Cooper M, Flinn I, Gersh R, Gordon D, Wilks ST, Klein A, Krauss JC, Lister J, Mandell L, Molina A, Pendergrass KB, Reeder C, Savin MA, Spitzer G, Tuscano JM, van Deventer H, Eradat HA, Cooper B, Masood A, Mena R.

Subjects
Oncology, Male, Chronic lymphocytic leukaemia, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Pharmacology, Antibodies, Monoclonal, Murine-Derived, Recurrence, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, drug therapy, Male, Middle Aged, Recurrence, Vidarabine, Chronic, Aged, 80 and over, Leukemia, Medicine (all), Antibodies, Monoclonal, Hematology, Middle Aged, Adult, Aged, Aged, Lymphocytic, Fludarabine, Tolerability, Small lymphocytic lymphoma, administration /&/ dosage/adverse effects, Female, Humans, Leukemia, Rituximab, Female, Vidarabine, medicine.drug, Adult, Murine-Derived, medicine.medical_specialty, Cyclophosphamide, chemical and pharmacologic phenomena, CD23, Lumiliximab, Aged, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Antibodies, chronic lymphocytic leukaemia, lumiliximab, small lymphocytic lymphoma, Internal medicine, administration /&/ dosage/adverse effects/analogs /&/ derivatives, 80 and over, Antibodie, Adverse effect, Lymphocytic leukaemia, business.industry, administration /&/ dosage/adverse effects, Antibodie, B-Cell, administration /&/ dosage/adverse effects, Cyclophosphamide, Interim analysis, administration /&/ dosage/adverse effects, Antineoplastic Combined Chemotherapy Protocol, business
Abstract

Item does not contain fulltext Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

Published
2014

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