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Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia.
- Source :
-
Leukemia & lymphoma [Leuk Lymphoma] 2016 Sep; Vol. 57 (9), pp. 2037-46. Date of Electronic Publication: 2016 Jan 19. - Publication Year :
- 2016
-
Abstract
- We report results of a randomized, phase III study of ofatumumab versus physicians' choice treatment in patients with bulky fludarabine-refractory chronic lymphocytic leukemia and explore extended versus standard-length ofatumumab treatment. Patients (79 ofatumumab, 43 physicians' choice) completed a median 6 (ofatumumab) or 3 (physicians' choice) months' therapy. Ofatumumab-treated patients with stable disease or better were randomized (2:1) to 6 months' extended ofatumumab treatment or observation. Although the study did not meet the primary endpoint of progression-free survival (PFS) by independent review committee (ofatumumab: 5.4 months, physicians' choice: 3.6 months; p = 0.27), median PFS by investigators was significantly longer for ofatumumab versus physicians' choice (7.0 versus 4.5 months; p = 0.003) as was time to next therapy (median 11.5 versus 6.5 months; p = 0.0004). PFS and time to next therapy were significantly longer with ofatumumab extended treatment than observation (p = 0.026 and p = 0.002, respectively; n = 37). The adverse-event profile of long-term ofatumumab administration showed no unexpected findings (Clinicaltrials.gov identifier: NCT01313689).
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal administration & dosage
Antibodies, Monoclonal adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols adverse effects
Drug Resistance, Neoplasm
Female
Humans
Leukemia, Lymphocytic, Chronic, B-Cell diagnosis
Leukemia, Lymphocytic, Chronic, B-Cell mortality
Male
Middle Aged
Treatment Outcome
Vidarabine administration & dosage
Vidarabine analogs & derivatives
Antibodies, Monoclonal therapeutic use
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1029-2403
- Volume :
- 57
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Leukemia & lymphoma
- Publication Type :
- Academic Journal
- Accession number :
- 26784000
- Full Text :
- https://doi.org/10.3109/10428194.2015.1122783