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.

Description

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.

Conditions

Chronic Lymphocytic Leukemia

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Study Overview

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Study Details

Study overview

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.

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.

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.

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Highlands Oncology Group, Fayetteville, Arkansas, United States, 72703

Aurora

Rocky Mountain Cancer Centers (Aurora) - USOR, Aurora, Colorado, United States, 80012

Athens

University Cancer and Blood Center, LLC, Athens, Georgia, United States, 30607

Fort Wayne

Fort Wayne Medical Oncology and Hematology, Inc, Fort Wayne, Indiana, United States, 46804

Bethesda

American Oncology Partners of Maryland, Pa, Bethesda, Maryland, United States, 20817

Grand Island

Nebraska Cancer Specialists St Francis - Grand Island, Grand Island, Nebraska, United States, 68803

Omaha

Nebraska Cancer Specialists, Omaha, Nebraska, United States, 68114

East Brunswick

Astera Cancer Care East Brunswick, East Brunswick, New Jersey, United States, 08816

Farmington

San Juan Oncology Associates, PC, Farmington, New Mexico, United States, 87401

Cincinnati

Oncology Hematology Care Inc - Cincinnati - USOR, Cincinnati, Ohio, United States, 45226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  • 2. Progressive or stable disease on cBTKi
  • 3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  • 4. History of cardiomyopathy
  • 5. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
  • 6. Clinically significant cardiovascular disease
  • 7. Active bleeding or history of bleeding diathesis
  • 8. Pregnant women and nursing mothers
  • 9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genentech, Inc.,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2028-02-08