← Back to Search

Tyrosine Kinase Inhibitor

Venetoclax + cBTKi for Chronic Lymphocytic Leukemia (BRAVE Trial)

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
Must not have
Progressive or stable disease on cBTKi
Active bleeding or history of bleeding diathesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Summary

This trial aims to see if adding venetoclax to patients with CLL who are already receiving cBTKi can lead to long-lasting remissions with undetectable residual disease in the blood,

Who is the study for?
This trial is for individuals with first-line Chronic Lymphocytic Leukemia (1L CLL) who are already receiving a cBTKi treatment. The study aims to see if adding Venetoclax can lead to deep remissions, allowing patients periods off treatment.
What is being tested?
The BRAVE study tests whether combining Venetoclax with an ongoing cBTKi therapy in 1L CLL patients leads to undetectable levels of residual disease, potentially enabling breaks from treatment.
What are the potential side effects?
Venetoclax may cause side effects like low blood cell counts, infections, fatigue, nausea, and diarrhea. Side effects vary by individual and should be discussed with the healthcare provider.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have CLL and have been on a stable dose of a cBTKi treatment for over 6 months with at least partial response.
Select...
I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My condition has not improved on cBTKi treatment.
Select...
I do not have active bleeding or a history of bleeding disorders.
Select...
I am currently pregnant or breastfeeding.
Select...
I have previously received Bcl-2 inhibitor therapy for cancer.
Select...
I have a serious heart condition.
Select...
I have an uncontrolled immune-related blood condition.
Select...
My CLL has transformed into a more aggressive form of lymphoma.
Select...
I have a history of heart muscle disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Undetected Minimal Residual Disease at 10^-4 (uMRD4) PB Rates at EOCT
Secondary study objectives
CR/CRi Rate as Determined by the Investigator According to iwCLL Guidelines
DOR with CR or CRi
Duration of Response (DOR)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax Added to cBTKi (Commercially Prescribed)Experimental Treatment2 Interventions
Participants will receive venetoclax, orally, once daily (QD) as ramp-up dosing at a starting dose of 20 milligrams (mg) on Day 1 of Cycle 1 (cycle length= 28 days) with weekly dose increases until the target dose of 400 mg is reached. Thereafter, participants will continue receiving venetoclax at 400 mg, orally, QD from Day 1 of Cycle 2 up to Day 28 of Cycle 12. Participants will continue receiving cBTKi-monotherapy (i.e. ibrutinib or acalabrutinib, or zanubrutinib) as previoulsy prescribed by the investigator in accordance with its prescribing label for up to 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,550 Previous Clinical Trials
568,264 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,316 Total Patients Enrolled
~67 spots leftby Feb 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top