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Leuk Lymphoma. 2017 May;58(5):1084-1093. doi: 10.1080/10428194.2016.1233536. Epub 2016 Oct 12.

Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial.

Author information

1
a Department of Hematology , Medical University of Lodz and Copernicus Memorial Hospital , Lodz , Poland.
2
b Department of Hematology , Institute of Hematology and Transfusion Medicine , Warsaw , Poland.
3
c Kidwai Memorial Institute of Oncology , Bangalore , India.
4
d HCG Curie Centre of Oncology , Bangalore , India.
5
e Makiivka City Hospital #2 of Donetsk Region , Makiivka , Ukraine.
6
f Department of Medical Oncology , Wrocław Medical University , Wrocław , Poland.
7
g Russian Research Institute of Hematology and Transfusiology , St. Petersburg , Russia.
8
h Hospital Universitario de La Princesa, IIS-IP , Madrid , Spain.
9
i Oncohematology Department , National Cancer Institute , Kiev , Ukraine.
10
j Medical University of Bialystok , Bialystok , Poland.
11
k Khmelnytskyi Regional Hospital , Khmelnytskyi , Ukraine.
12
l Department of Hematology , Janusz Korczak Hospital , Słupsk , Poland.
13
m Novartis , Uxbridge , UK.
14
n GlaxoSmithKline , Collegeville , PA , USA.
15
o Novartis, Research Triangle Park , Durham , NC , USA.
16
p Genmab , Copenhagen , Denmark.
17
q Novartis , King of Prussia , PA , USA.
18
r Department of Cancer Prevention, Faculty of Public Heath , Medical University of Silesia , Katowice , Poland.

Abstract

In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC: n = 183; FC: n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0.67; 95% confidence interval, 0.51-0.88; p = .0032). Grade ≥3 adverse events (≤60 days after last dose) were reported in 134 (74%) OFA + FC-treated patients compared with 123 (69%) FC-treated patients. Of these, neutropenia was the most common (89 [49%] vs. 64 [36%]). OFA + FC improved PFS with manageable safety for patients with relapsed CLL compared with FC alone, thus providing an alternative treatment option for patients with relapsed CLL.

TRIAL REGISTRATION:

www.clinicaltrials.gov (NCT00824265).

KEYWORDS:

FC; Ofatumumab; chemoimmunotherapy; phase III clinical trial; relapsed CLL

PMID:
27731748
DOI:
10.1080/10428194.2016.1233536
[Indexed for MEDLINE]

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