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

NCT06524375 · tracked via the Priya Life Science USA tracker

Sponsor

Genentech, Inc.

Phase

Phase 2

Started

2024-08-09

Last updated

2026-02-25

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

VenetoclaxcBTKi Monotherapy

Venetoclax: Venetoclax tablets will be administered as per the schedule specified in the arm.

cBTKi Monotherapy: Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 (\</=) 2 3. Adequate renal and liver function Exclusion Criteria: 1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy 2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening 3. Progressive or stable disease on cBTKi 4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia) 5. History of cardiomyopathy 6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose) 7. Clinically significant cardiovascular disease 8. Active bleeding or history of bleeding diathesis 9. Pregnant women and nursing mothers 10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Primary outcome measure(s)

uMRD4 Rate at EOCT — Cycle 12 Day 28 (Cycle length= 28 Days)
uMRD4 will be assessed using next generation sequencing (NGS) (sensitivity 10\^-4) from PB.

Trial sites (20)

Facility	City	Region
Highlands Oncology Group	Springdale	Arkansas
Rocky Mountain Cancer Centers (Aurora) - USOR	Aurora	Colorado
Cancer Specialists of North Florida	Jacksonville	Florida
Fort Wayne Medical Oncology and Hematology, Inc	Fort Wayne	Indiana
Mission Blood and Cancer - MercyOne Cancer Center	Des Moines	Iowa
American Oncology Partners of Maryland, PA	Bethesda	Maryland
Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center	Boston	Massachusetts
Nebraska Cancer Specialists St Francis - Grand Island	Grand Island	Nebraska
Nebraska Cancer Specialists	Omaha	Nebraska
Astera Cancer Care East Brunswick	East Brunswick	New Jersey
San Juan Oncology Associates, PC	Farmington	New Mexico
Oncology Hematology Care Inc - Cincinnati - USOR	Cincinnati	Ohio
Ohio State University	Columbus	Ohio
Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
Asante Rogue Regional Medical Center	Medford	Oregon
Tennessee Oncology, PLLC - Chattanooga	Chattanooga	Tennessee
Tennessee Oncology - Midtown	Nashville	Tennessee
MD Anderson Cancer Center	Houston	Texas
Texas Oncology- Northeast Texas	Tyler	Texas
Medical College of Wisconsin	Milwaukee	Wisconsin

On this site

📄 Venclexta (venetoclax) drug profile →

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Other trials for the same condition

A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia Recruiting

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A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06524375 on ClinicalTrials.gov ↗ ← All trials in the USA