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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.

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06524375
Protocol IDs
Study Sponsor
Genentech Inc.

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

  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 (
  3. Adequate renal and liver function

Treatment Sites in Georgia

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.