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Trial Title:
A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-Line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-Treatment Period.
NCT ID:
NCT06524375
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax tablets will be administered as per the schedule specified in the arm.
Arm group label:
Venetoclax Added to cBTKi (Commercially Prescribed)
Other name:
RO5537382
Intervention type:
Drug
Intervention name:
cBTKi Monotherapy
Description:
Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be
administered in accordance with its prescribing label.
Arm group label:
Venetoclax Added to cBTKi (Commercially Prescribed)
Summary:
The main purpose of the study is to evaluate if adding venetoclax to participants
receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable
measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of
combination treatment (EOCT) to allow off-treatment period.
The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment
periods) with VEnetoclax.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib,
acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a
response of at least a PR per iwCLL criteria
2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to
(
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rocky Mountain Cancer Centers (Aurora) - USOR
Address:
City:
Aurora
Zip:
80012
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology, Inc
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Cancer Specialists St Francis - Grand Island
Address:
City:
Grand Island
Zip:
68803
Country:
United States
Status:
Recruiting
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68114
Country:
United States
Status:
Recruiting
Facility:
Name:
Astera Cancer Care East Brunswick
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Facility:
Name:
San Juan Oncology Associates, PC
Address:
City:
Farmington
Zip:
87401
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Hematology Care Inc - Cincinnati - USOR
Address:
City:
Cincinnati
Zip:
45226
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Associates of Oregon, P.C.
Address:
City:
Eugene
Zip:
97401
Country:
United States
Status:
Recruiting
Facility:
Name:
Texas Oncology- Northeast Texas
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Start date:
August 9, 2024
Completion date:
February 8, 2028
Lead sponsor:
Agency:
Genentech, Inc.
Agency class:
Industry
Source:
Genentech, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06524375
