PMID- 33243049
OWN - NLM
STAT- MEDLINE
DCOM- 20210430
LR  - 20210430
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 62
IP  - 4
DP  - 2021 Apr
TI  - Phase 2, multicenter GIBB study of obinutuzumab plus bendamustine in previously 
      untreated patients with chronic lymphocytic leukemia.
PG  - 791-800
LID - 10.1080/10428194.2020.1850719 [doi]
AB  - The single-arm, multicenter, phase 2 GIBB study (NCT02320487) investigated 
      bendamustine plus obinutuzumab (BG) in previously untreated CLL. Patients 
      (N = 102) received six cycles of intravenous obinutuzumab (cycle [C] 1: 100 mg 
      day 1/900 mg day 2, and 1000 mg days 8/15; C2-6 1000 mg day 1) plus bendamustine 
      (C1 90 mg/m(2) days 2/3; C2-6 days 1/2). Complete response (CR), the primary 
      endpoint, was 50%, overall response 89%. Estimated 2-year progression-free 
      survival (PFS) and overall survival (OS) were 86% and 97%, respectively. 
      Following initial minimal residual disease (MRD) negativity, median MRD 
      negativity duration was 28.9 months. Undetectable MRD (<10(-4)) was observed in 
      up to 83% of evaluable patients in peripheral blood (any time) and 59% in bone 
      marrow at response evaluation. Most common grade 3/4 adverse events (AEs) were 
      neutropenia (25%; 5% febrile) and infusion-related reactions (9%). BG proved 
      clinically active in CLL with high response, MRD negativity, and survival rates, 
      consistent with other first-line studies of anti-CD20 antibody/bendamustine 
      combinations.
FAU - Sharman, Jeff P
AU  - Sharman JP
AD  - Willamette Valley Cancer Institute and Research Center, US Oncology Research, 
      Eugene, OR, USA.
FAU - Burke, John M
AU  - Burke JM
AD  - Rocky Mountain Cancer Centers, US Oncology Research, Aurora, CO, USA.
FAU - Yimer, Habte A
AU  - Yimer HA
AD  - Texas Oncology, US Oncology Research, Tyler, TX, USA.
FAU - Boxer, Michael A
AU  - Boxer MA
AD  - Arizona Oncology, US Oncology Research, Tucson, AZ, USA.
FAU - Babu, Sunil
AU  - Babu S
AD  - Fort Wayne Medical Oncology, Fort Wayne, IN, USA.
FAU - Li, Jia
AU  - Li J
AD  - Genentech Inc, South San Francisco, CA, USA.
FAU - Mun, Yong
AU  - Mun Y
AD  - Genentech Inc, South San Francisco, CA, USA.
FAU - Danilov, Alexey V
AU  - Danilov AV
AD  - Oregon Health and Science University, Portland, OR, USA.
AD  - City of Hope National Medical Center, Duarte, CA, USA.
CN  - GIBB study investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02320487
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201126
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 981Y8SX18M (Bendamustine Hydrochloride)
RN  - O43472U9X8 (obinutuzumab)
SB  - IM
MH  - Antibodies, Monoclonal, Humanized/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Bendamustine Hydrochloride/therapeutic use
MH  - Humans
MH  - *Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy
MH  - Rituximab/therapeutic use
OTO - NOTNLM
OT  - Bendamustine
OT  - chronic lymphocytic leukemia
OT  - minimal residual disease
OT  - obinutuzumab
OT  - survival
EDAT- 2020/11/28 06:00
MHDA- 2021/05/01 06:00
CRDT- 2020/11/27 05:28
PHST- 2020/11/28 06:00 [pubmed]
PHST- 2021/05/01 06:00 [medline]
PHST- 2020/11/27 05:28 [entrez]
AID - 10.1080/10428194.2020.1850719 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2021 Apr;62(4):791-800. doi: 10.1080/10428194.2020.1850719. Epub 
      2020 Nov 26.