RECRUITING

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.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2024-08-09
Study Completion:2028-02-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06524375

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2
  3. 3. Adequate renal and liver function
  1. 1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy
  2. 2. Progressive or stable disease on cBTKi
  3. 3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
  4. 4. History of cardiomyopathy
  5. 5. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
  6. 6. Clinically significant cardiovascular disease
  7. 7. Active bleeding or history of bleeding diathesis
  8. 8. Pregnant women and nursing mothers
  9. 9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Contacts and Locations

Study Contact

Reference Study ID Number: ML45219 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Highlands Oncology Group
Fayetteville, Arkansas, 72703
United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, 80012
United States
University Cancer and Blood Center, LLC
Athens, Georgia, 30607
United States
Fort Wayne Medical Oncology and Hematology, Inc
Fort Wayne, Indiana, 46804
United States
American Oncology Partners of Maryland, Pa
Bethesda, Maryland, 20817
United States
Nebraska Cancer Specialists St Francis - Grand Island
Grand Island, Nebraska, 68803
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68114
United States
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
United States
San Juan Oncology Associates, PC
Farmington, New Mexico, 87401
United States
Oncology Hematology Care Inc - Cincinnati - USOR
Cincinnati, Ohio, 45226
United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504-8332
United States
Texas Oncology- Northeast Texas
Tyler, Texas, 75702
United States

Collaborators and Investigators

Sponsor: Genentech, Inc.

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-09
Study Completion Date2028-02-08

Study Record Updates

Study Start Date2024-08-09
Study Completion Date2028-02-08

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Lymphocytic Leukemia