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).

journal_name

Leuk Lymphoma

journal_title

Leukemia & lymphoma

authors

Österborg A,Udvardy M,Zaritskey A,Andersson PO,Grosicki S,Mazur G,Kaplan P,Steurer M,Schuh A,Montillo M,Kryachok I,Middeke JM,Kulyaba Y,Rekhtman G,Gorczyca M,Daly S,Chang CN,Lisby S,Gupta I

doi

10.3109/10428194.2015.1122783

subject

Has Abstract

pub_date

2016-09-01 00:00:00

pages

2037-46

issue

9

eissn

1042-8194

issn

1029-2403

journal_volume

57

pub_type

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