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NCT06524375Active, not recruitingPhase 2

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

Phase II, Open-label, Prospective Single-arm, Multi-center Clinical Trial to Evaluate if Adding Venetoclax to Patients on Covalent BTKi For 1L CLL Can Achieve Deep Durable Remissions (by UMRD 10^-4) to Allow Off-treatment Period

Source: ClinicalTrials.gov · Last updated 28 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
118 (actual)
First submitted
23 Jul 2024
Start date
9 Aug 2024
Primary completion date
31 Oct 2026
Lead sponsor
Genentech, Inc.
NCT number
NCT06524375

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 118
  • From 9 Aug 2024 to the primary completion date, 31 Oct 2026
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  • Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening

Other illness

  • Progressive or stable disease on cBTKi
  • History of cardiomyopathy
  • Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
  • Clinically significant cardiovascular disease
  • Active bleeding or history of bleeding diathesis
  • Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Other

  • Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  • Pregnant women and nursing mothers

Who the study is looking for

  • 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
  • Adequate renal and liver function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rocky Mountain Cancer Centers (Aurora) - USOR
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AuroraUnited StatesUnknown status
American Oncology Partners of Maryland, PA
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BethesdaUnited StatesUnknown status
Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center
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BostonUnited StatesUnknown status
Tennessee Oncology PLLC - Chattanooga
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ChattanoogaUnited StatesUnknown status
Oncology Hematology Care Inc - Cincinnati - USOR
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CincinnatiUnited StatesUnknown status
Ohio State University
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ColumbusUnited StatesUnknown status
Mission Blood and Cancer - MercyOne Cancer Center
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Des MoinesUnited StatesUnknown status
Astera Cancer Care - East Brunswick
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East BrunswickUnited StatesUnknown status
Willamette Valley Cancer Institute and Research Center
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EugeneUnited StatesUnknown status
San Juan Oncology Associates, PC
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FarmingtonUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc
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Fort WayneUnited StatesUnknown status
Nebraska Cancer Specialists St Francis - Grand Island
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Grand IslandUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Cancer Specialists of North Florida
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JacksonvilleUnited StatesUnknown status
Asante Rogue Regional Medical Center
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MedfordUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Tennessee Oncology - Midtown
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NashvilleUnited StatesUnknown status
Nebraska Cancer Specialists
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OmahaUnited StatesUnknown status
Highlands Oncology Group
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SpringdaleUnited StatesUnknown status
Texas Oncology - Northeast Texas
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TylerUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.