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.

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).

• Authors: Anders Österborg, Miklós Udvardy, Andrey Zaritskey, Per-Ola Andersson, Sebastian Grosicki, Grzegorz Mazur, Polina Kaplan, Michael Steurer, Anna Schuh, Marco Montillo, Iryna Kryachok, Jan Moritz Middeke, Yaroslav Kulyaba, Grygoriy Rekhtman, Michele Gorczyca, Siobhan Daly, Chai-Ni Chang, Steen Lisby, Ira Gupta
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 57 Issue 9 Pg. 2037-46 (09 2016) ISSN: 1029-2403 [Electronic] United States
• PMID: 26784000 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Vidarabine
• ofatumumab
• fludarabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Drug Resistance, Neoplasm
• Female
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (diagnosis, drug therapy, mortality)
• Male
• Middle Aged
• Treatment Outcome
• Vidarabine (administration & dosage, analogs & derivatives)