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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

No Placebo-Only Group

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

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I have CLL and have been on a stable dose of a cBTKi treatment for over 6 months with at least partial response.

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I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition has not improved on cBTKi treatment.

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I do not have active bleeding or a history of bleeding disorders.

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I am currently pregnant or breastfeeding.

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I have previously received Bcl-2 inhibitor therapy for cancer.

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I have a serious heart condition.

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I have an uncontrolled immune-related blood condition.

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My CLL has transformed into a more aggressive form of lymphoma.

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I have a history of heart muscle disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met