PMID- 24717109
OWN - NLM
STAT- MEDLINE
DCOM- 20151007
LR  - 20191210
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 56
IP  - 1
DP  - 2015 Jan
TI  - Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal 
      antibody, in low-affinity FcgammaRIIIa patients with previously treated follicular 
      lymphoma.
PG  - 42-8
LID - 10.3109/10428194.2014.911859 [doi]
AB  - This phase 2 study assessed the safety and efficacy of ocaratuzumab, a humanized 
      anti-CD20 monoclonal antibody. Fifty patients with previously treated follicular 
      lymphoma (FL) and a low-affinity genotype of FcgammaRIIIa received ocaratuzumab 375 
      mg/m(2) weekly for 4 weeks. Grade 3/4/5 adverse events (AEs) were reported in 
      11/1/1 patients, respectively. Serious AEs were reported by 11/50 patients, and 
      three discontinued due to AEs. One patient died from aspiration pneumonia due to 
      possibly drug-related nausea and vomiting. Investigator-assessed response rate 
      was 30% (15/50), including four complete responses (CR), three CR unconfirmed 
      (CRu) and eight partial responses (PR). Investigator-assessed median 
      Progression-free survivial (PFS) was 38.3 weeks. Ocaratuzumab's pharmacokinetic 
      profile was similar to that reported for rituximab. Lymphocyte subset analysis 
      showed significant, selective reduction of B-cells during and after ocaratuzumab 
      treatment. Ocaratuzumab at this dose and schedule is active and well tolerated in 
      patients with previously treated FL with low affinity FcgammaRIIIa genotypes. 
      ClinTrials registry number: NCT00354926.
FAU - Ganjoo, Kristen N
AU  - Ganjoo KN
AD  - Stanford Cancer Center , Stanford, CA , USA.
FAU - de Vos, Sven
AU  - de Vos S
FAU - Pohlman, Brad L
AU  - Pohlman BL
FAU - Flinn, Ian W
AU  - Flinn IW
FAU - Forero-Torres, Andres
AU  - Forero-Torres A
FAU - Enas, Nathan H
AU  - Enas NH
FAU - Cronier, Damien M
AU  - Cronier DM
FAU - Dang, Nam H
AU  - Dang NH
FAU - Foon, Kenneth A
AU  - Foon KA
FAU - Carpenter, Susan P
AU  - Carpenter SP
FAU - Slapak, Christopher A
AU  - Slapak CA
FAU - Link, Brian K
AU  - Link BK
FAU - Smith, Mitchell R
AU  - Smith MR
FAU - Mapara, Markus Y
AU  - Mapara MY
FAU - Wooldridge, James E
AU  - Wooldridge JE
LA  - eng
SI  - ClinicalTrials.gov/NCT00354926
PT  - Case Reports
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140714
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (FCGR3A protein, human)
RN  - 0 (Receptors, IgG)
RN  - NTY9893GD0 (ocaratuzumab)
SB  - IM
CIN - Leuk Lymphoma. 2015 Jan;56(1):1-2. PMID: 24898669
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Alleles
MH  - Antibodies, Monoclonal, Humanized/pharmacology/*therapeutic use
MH  - Antineoplastic Agents/pharmacology/*therapeutic use
MH  - Female
MH  - Heterozygote
MH  - Humans
MH  - Lymphoma, Follicular/*drug therapy/*metabolism/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Polymorphism, Single Nucleotide
MH  - Receptors, IgG/genetics/*metabolism
MH  - Retreatment
MH  - Treatment Outcome
OTO - NOTNLM
OT  - FcgammaRIIIa
OT  - Follicular lymphoma
OT  - ocaratuzumab
EDAT- 2014/04/11 06:00
MHDA- 2015/10/08 06:00
CRDT- 2014/04/11 06:00
PHST- 2014/04/11 06:00 [entrez]
PHST- 2014/04/11 06:00 [pubmed]
PHST- 2015/10/08 06:00 [medline]
AID - 10.3109/10428194.2014.911859 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2015 Jan;56(1):42-8. doi: 10.3109/10428194.2014.911859. Epub 2014 
      Jul 14.