Journal article
A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab
British journal of haematology, Vol.177(2), pp.243-253
04/2017
DOI: 10.1111/bjh.14534
PMCID: PMC5412890
PMID: 28220479
Abstract
This phase 1/2 study evaluated the safety, pharmacokinetic behavior and anti-tumour activity of ublituximab, a unique type I, chimeric, glycoengineered anti-CD20 monoclonal antibody, in rituximab-relapsed or -refractory patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukaemia (CLL). Induction therapy (doses of 450-1200mg) consisted of 4 weekly infusions in cycle 1 for NHL and 3 weekly infusions in cycles 1 and 2 for CLL. Patients received ublituximab maintenance monthly during cycles 3-5, then once every 3months for up to 2years. Enrolled patients with B-NHL (n=27) and CLL (n=8) had a median of 3 prior therapies. No dose-limiting toxicities or unexpected adverse events (AEs) occurred. The most common AEs were infusion-related reactions (40%; grade 3/4, 0%); fatigue (37%; grade 3/4, 3%); pyrexia (29%; grade 3/4, 0%); and diarrhoea (26%; grade 3/4, 0%). Common haematological AEs were neutropenia (14%; grade 3/4, 14%) and anaemia (11%; grade 3/4, 6%). The overall response rate for evaluable patients (n=31) was 45% (13% complete responses, 32% partial responses). Median duration of response and progression-free survival were 92months and 77months, respectively. Ublituximab was well-tolerated and efficacious in a heterogeneous and highly rituximab-pre-treated patient population.
Details
- Title: Subtitle
- A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab
- Creators
- Ahmed Sawas - Columbia UniversityCharles M. Farber - Carol G Simon Canc Ctr, Morristown, NJ USAMarshall T. Schreeder - Clearview Canc Inst, Huntsville, AL USAMazen Y. Khalil - St Bernards Clopton Clin, Jonesboro, AR USADaruka Mahadevan - West Clin, Memphis, TN USAChangchun Deng - Columbia UniversityJennifer E. Amengual - Columbia UniversityPetros G. Nikolinakos - Univ Canc & Blood Ctr, Athens, GA USAJill M. Kolesar - Univ Wisconsin, Carbone Comprehens Canc Ctr, Madison, WI USAJohn G. Kuhn - Univ Texas Hlth Sci Ctr San Antonio, San Antonio, TX 78229 USAPeter Sportelli - TG Therapeut Inc, New York, NY USAHari P. Miskin - TG Therapeut Inc, New York, NY USAOwen A. O'Connor - Columbia University
- Resource Type
- Journal article
- Publication Details
- British journal of haematology, Vol.177(2), pp.243-253
- DOI
- 10.1111/bjh.14534
- PMID
- 28220479
- PMCID
- PMC5412890
- NLM abbreviation
- Br J Haematol
- ISSN
- 0007-1048
- eISSN
- 1365-2141
- Publisher
- Wiley
- Number of pages
- 11
- Grant note
- Lymphoma Research Fund at Columbia University TG Therapeutics, Inc.
- Language
- English
- Date published
- 04/2017
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984695791202771
Metrics
20 Record Views