Obinutuzumab plus fludarabine/cyclophosphamide or bendamustine in the initial therapy of CLL patients: The phase 1b GALTON trial

Blood

Volumn 125, Issue 18, 2015, Pages 2779-2785

  Brown, Jennifer R ^a,b   O'Brien, Susan ^c   Kingsley, C Daniel ^d   Eradat, Herbert ^e   Pagel, John M ^f   Lymp, James ^g   Hirata, Jamie ^g   Kipps, Thomas J ^b,h  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b CLL Research Consortium   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d Clearview Cancer Institute   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^g GENENTECH INC   (United States)

^h UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BENDAMUSTINE; CYCLOPHOSPHAMIDE; FLUDARABINE; IMMUNOGLOBULIN A; IMMUNOGLOBULIN CLASS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; OBINUTUZUMAB; ANTINEOPLASTIC AGENT; CHLORMETHINE DERIVATIVE; MONOCLONAL ANTIBODY; VIDARABINE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; APPENDICITIS; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER THERAPY; CAUSE OF DEATH; CELLULITIS; CHEMOTHERAPY INDUCED ANEMIA; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CONFERENCE PAPER; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; INFECTION COMPLICATION; INFUSION RELATED REACTION; LEUKEMIA RELAPSE; MALE; MIDDLE AGED; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; PANCYTOPENIA; PARONYCHIA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SKIN INFECTION; THROMBOCYTOPENIA; TOOTH INFECTION; TOXIC HEPATITIS; TREATMENT RESPONSE; TUMOR LYSIS SYNDROME; ADJUVANT THERAPY; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENDAMUSTINE HYDROCHLORIDE; CYCLOPHOSPHAMIDE; FEMALE; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; NEOADJUVANT THERAPY; NITROGEN MUSTARD COMPOUNDS; TREATMENT OUTCOME; VIDARABINE;

EID: 84928799883     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-12-613570     Document Type: Conference Paper

References (18)

1. Byrd JC, Rai K, Peterson BL, et al. Addition of rituximab to fludarabine may prolong progressionfree survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood. 2005;105(1):49-53.
2. Hallek M, Fischer K, Fingerle-Rowson G, et al; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010;376(9747):1164-1174.
3. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23(18):4079-4088.
4. Fischer K, Cramer P, Busch R, et al. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012;30(26): 3209-3216.
5. Fischer K, Cramer P, Busch R, et al. Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2011;29(26): 3559-3566.
6. Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. J Clin Oncol. 2009;27(26):4378-4384.
7. Alduaij W, Ivanov A, Honeychurch J, et al. Novel type II anti-CD20 monoclonal antibody (GA101) evokes homotypic adhesion and actin-dependent, lysosome-mediated cell death in B-cell malignancies. Blood. 2011;117(17):4519-4529.
8. Mössner E, Brünker P, Moser S, et al. Increasing the efficacy of CD20 antibody therapy through the engineering of a new type II anti-CD20 antibody with enhanced direct and immune effector cellmediated B-cell cytotoxicity. Blood. 2010;115(22): 4393-4402.
9. Golay J, Da Roit F, Bologna L, et al. Glycoengineered CD20 antibody obinutuzumab activates neutrophils and mediates phagocytosis through CD16B more efficiently than rituximab. Blood. 2013;122(20):3482-3491.
10. Patz M, Isaeva P, Forcob N, et al. Comparison of the in vitro effects of the anti-CD20 antibodies rituximab and GA101 on chronic lymphocytic leukaemia cells. Br J Haematol. 2011;152(3): 295-306.
11. Salles G, Morschhauser F, Lamy T, et al. Phase 1 study results of the type II glycoengineered humanized anti-CD20 monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients. Blood. 2012;119(22):5126-5132.
12. Sehn LH, Assouline SE, Stewart DA, et al. A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood. 2012;119(22):5118-5125.
13. Goede V, Fischer K, Busch R, et al. Chemoimmunotherapy with GA101 plus chlorambucil in patients with chronic lymphocytic leukemia and comorbidity: results of the CLL11 (BO21004) safety run-in. Leukemia. 2013;27(5): 1172-1174.
14. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370(12):1101-1110.
15. Hallek M, Cheson BD, Catovsky D, et al; International Workshop on Chronic Lymphocytic Leukemia. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood. 2008;111(12): 5446-5456.
16. Eichhorst B, Fink AM, Busch R, et al. Frontline chemoimmunotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) shows superior efficacy in comparison to bendamustine (B) and rituximab (BR) in previously untreated and physically fit patients (pts) with advanced chronic lymphocytic leukemia (CLL): final analysis of an international, randomized study of the German CLL Study Group (GCLLSG) (CLL10 Study). Blood. 2014; 124(21):19.
17. Freeman CL, Morschhauser F, Sehn LH, et al. Pattern of cytokine release in patients with chronic lymphocytic leukemia treated with obinutuzumab and possible relationship with development of infusion related reactions (IRR). Blood. 2014; 124(21):4674.
18. Bosch F, Illmer T, Turgut M, et al. Preliminary safety results from the phase IIIb GREEN study of obinutuzumab (GA101) alone or in combination with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). Blood. 2014; 124(21):3345