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Venetoclax In CLL Patients on BTKi Therapy to Optimize dept of Response for time off therapy (BRAVE)

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
, 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

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. 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

Treatment Sites in Georgia

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