PMID- 22431570
OWN - NLM
STAT- MEDLINE
DCOM- 20120730
LR  - 20220310
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Linking)
VI  - 119
IP  - 22
DP  - 2012 May 31
TI  - Phase 1 study results of the type II glycoengineered humanized anti-CD20 
      monoclonal antibody obinutuzumab (GA101) in B-cell lymphoma patients.
PG  - 5126-32
LID - 10.1182/blood-2012-01-404368 [doi]
AB  - Whereas the chimeric type I anti-CD20 Ab rituximab has improved outcomes for 
      patients with B-cell malignancies significantly, many patients with non-Hodgkin 
      lymphoma (NHL) remain incurable. Obinutuzumab (GA101) is a glycoengineered, 
      humanized anti-CD20 type II Ab that has demonstrated superior activity against 
      type I Abs in vitro and in preclinical studies. In the present study, we 
      evaluated the safety, efficacy, and pharmacokinetics of GA101 in a phase 1 study 
      of 21 patients with heavily pretreated, relapsed, or refractory CD20(+) indolent 
      NHL. Patients received GA101 in a dose-escalating fashion (3 per cohort, range 
      50/100-1200/2000 mg) for 8 x 21-day cycles. The majority of adverse events (AEs) 
      were grades 1 and 2 (114 of 132 total AEs). Seven patients reported a total of 18 
      grade 3 or 4 AEs. Infusion-related reactions were the most common AE, with most 
      occurring during the first infusion and resolving with appropriate management. 
      Three patients experienced grade 3 or 4 drug-related infusion-related reactions. 
      The best overall response was 43%, with 5 complete responses and 4 partial 
      responses. Data from this study suggest that GA101 was well tolerated and 
      demonstrated encouraging activity in patients with previously treated NHL up to 
      doses of 2000 mg. This trial is registered at www.clinicaltrials.gov as 
      NCT00517530.
FAU - Salles, Gilles
AU  - Salles G
AD  - Hospices Civils de Lyon, Hematologie, Universite de Lyon, Unite Mixte de 
      Recherche (UMR) 5239, Centre National de la Recherche Scientifique (CNRS), 
      Pierre-Benite, France. gilles.salles@chu-lyon.fr
FAU - Morschhauser, Franck
AU  - Morschhauser F
FAU - Lamy, Thierry
AU  - Lamy T
FAU - Milpied, Noel
AU  - Milpied N
FAU - Thieblemont, Catherine
AU  - Thieblemont C
FAU - Tilly, Herve
AU  - Tilly H
FAU - Bieska, Gabi
AU  - Bieska G
FAU - Asikanius, Elina
AU  - Asikanius E
FAU - Carlile, David
AU  - Carlile D
FAU - Birkett, Joe
AU  - Birkett J
FAU - Pisa, Pavel
AU  - Pisa P
FAU - Cartron, Guillaume
AU  - Cartron G
LA  - eng
SI  - ClinicalTrials.gov/NCT00517530
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120319
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antigens, CD20)
RN  - O43472U9X8 (obinutuzumab)
SB  - IM
CIN - Blood. 2012 May 31;119(22):5061-3. PMID: 22653951
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/*adverse effects
MH  - *Antigens, CD20
MH  - Female
MH  - Humans
MH  - Lymphoma, B-Cell/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Time Factors
EDAT- 2012/03/21 06:00
MHDA- 2012/07/31 06:00
CRDT- 2012/03/21 06:00
PHST- 2012/03/21 06:00 [entrez]
PHST- 2012/03/21 06:00 [pubmed]
PHST- 2012/07/31 06:00 [medline]
AID - S0006-4971(20)47763-8 [pii]
AID - 10.1182/blood-2012-01-404368 [doi]
PST - ppublish
SO  - Blood. 2012 May 31;119(22):5126-32. doi: 10.1182/blood-2012-01-404368. Epub 2012 
      Mar 19.