PMID- 28220479
OWN - NLM
STAT- MEDLINE
DCOM- 20170614
LR  - 20190103
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Print)
IS  - 0007-1048 (Linking)
VI  - 177
IP  - 2
DP  - 2017 Apr
TI  - 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.
PG  - 243-253
LID - 10.1111/bjh.14534 [doi]
AB  - 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 450-1200 mg) 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 3 months for 
      up to 2 years. 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 
      9.2 months and 7.7 months, respectively. Ublituximab was well-tolerated and 
      efficacious in a heterogeneous and highly rituximab-pre-treated patient 
      population.
CI  - (c) 2017 The Authors. British Journal of Haematology published by John Wiley & Sons 
      Ltd.
FAU - Sawas, Ahmed
AU  - Sawas A
AD  - Center for Lymphoid Malignancies, Columbia University Medical Center, New York, 
      NY, USA.
FAU - Farber, Charles M
AU  - Farber CM
AD  - Carol G. Simon Cancer Center, Morristown, NJ, USA.
FAU - Schreeder, Marshall T
AU  - Schreeder MT
AD  - Clearview Cancer Institute, Huntsville, AL, USA.
FAU - Khalil, Mazen Y
AU  - Khalil MY
AD  - St. Bernards Clopton Clinic, Jonesboro, AR, USA.
FAU - Mahadevan, Daruka
AU  - Mahadevan D
AD  - The West Clinic, Memphis, TN, USA.
FAU - Deng, Changchun
AU  - Deng C
AD  - Center for Lymphoid Malignancies, Columbia University Medical Center, New York, 
      NY, USA.
FAU - Amengual, Jennifer E
AU  - Amengual JE
AD  - Center for Lymphoid Malignancies, Columbia University Medical Center, New York, 
      NY, USA.
FAU - Nikolinakos, Petros G
AU  - Nikolinakos PG
AD  - University Cancer and Blood Center, Athens, GA, USA.
FAU - Kolesar, Jill M
AU  - Kolesar JM
AD  - Carbone Comprehensive Cancer Center, University of Wisconsin, Madison, WI, USA.
FAU - Kuhn, John G
AU  - Kuhn JG
AD  - University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
FAU - Sportelli, Peter
AU  - Sportelli P
AD  - TG Therapeutics Inc., New York, NY, USA.
FAU - Miskin, Hari P
AU  - Miskin HP
AD  - TG Therapeutics Inc., New York, NY, USA.
FAU - O'Connor, Owen A
AU  - O'Connor OA
AD  - Center for Lymphoid Malignancies, Columbia University Medical Center, New York, 
      NY, USA.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170221
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antineoplastic Agents)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - U59UGK3IPC (ublituximab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal/*adverse effects/*therapeutic use
MH  - Antineoplastic Agents/administration & dosage/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Rituximab/*therapeutic use
PMC - PMC5412890
OTO - NOTNLM
OT  - B-cell lymphoma
OT  - LFB-R603
OT  - TG-1101
OT  - anti-CD20 monoclonal antibody
OT  - ublituximab
EDAT- 2017/02/22 06:00
MHDA- 2017/06/15 06:00
PMCR- 2017/05/02
CRDT- 2017/02/22 06:00
PHST- 2016/08/12 00:00 [received]
PHST- 2016/11/03 00:00 [accepted]
PHST- 2017/02/22 06:00 [pubmed]
PHST- 2017/06/15 06:00 [medline]
PHST- 2017/02/22 06:00 [entrez]
PHST- 2017/05/02 00:00 [pmc-release]
AID - BJH14534 [pii]
AID - 10.1111/bjh.14534 [doi]
PST - ppublish
SO  - Br J Haematol. 2017 Apr;177(2):243-253. doi: 10.1111/bjh.14534. Epub 2017 Feb 21.