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

Anders Österborg, M. 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

Research output: Contribution to journalArticle

8 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalLeukemia and Lymphoma
DOIs
Publication statusAccepted/In press - Jan 18 2016

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B-Cell Chronic Lymphocytic Leukemia
Physicians
Disease-Free Survival
Therapeutics
Observation
fludarabine
ofatumumab
Advisory Committees
Research Personnel

Keywords

  • Anti-CD20 monoclonal antibody
  • chronic lymphocytic leukemia
  • extended-length therapy
  • ofatumumab
  • phase III clinical trial

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

Cite this

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. / Österborg, Anders; Udvardy, M.; Zaritskey, Andrey; Andersson, Per Ola; Grosicki, Sebastian; Mazur, Grzegorz; Kaplan, Polina; Steurer, Michael; Schuh, Anna; Montillo, Marco; Kryachok, Iryna; Middeke, Jan Moritz; Kulyaba, Yaroslav; Rekhtman, Grygoriy; Gorczyca, Michele; Daly, Siobhan; Chang, Chai Ni; Lisby, Steen; Gupta, Ira.

In: Leukemia and Lymphoma, 18.01.2016, p. 1-10.

Research output: Contribution to journalArticle

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 2016, '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', Leukemia and Lymphoma, pp. 1-10. https://doi.org/10.3109/10428194.2015.1122783
Österborg, Anders ; Udvardy, M. ; Zaritskey, Andrey ; Andersson, Per Ola ; Grosicki, Sebastian ; Mazur, Grzegorz ; Kaplan, Polina ; Steurer, Michael ; Schuh, Anna ; Montillo, Marco ; Kryachok, Iryna ; Middeke, Jan Moritz ; Kulyaba, Yaroslav ; Rekhtman, Grygoriy ; Gorczyca, Michele ; Daly, Siobhan ; Chang, Chai Ni ; Lisby, Steen ; Gupta, Ira. / 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. In: Leukemia and Lymphoma. 2016 ; pp. 1-10.
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AU - Grosicki, Sebastian

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AU - Kaplan, Polina

AU - Steurer, Michael

AU - Schuh, Anna

AU - Montillo, Marco

AU - Kryachok, Iryna

AU - Middeke, Jan Moritz

AU - Kulyaba, Yaroslav

AU - Rekhtman, Grygoriy

AU - Gorczyca, Michele

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AU - Chang, Chai Ni

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