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Evaluating venetoclax with cBTKi for chronic lymphocytic leukemia treatment

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.

PHASE2 · Genentech, Inc. · NCT06524375

This study is testing if adding venetoclax to the treatment of people with chronic lymphocytic leukemia who are already on a specific medication can help them achieve better and longer-lasting results.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorGenentech, Inc. (industry)
Drugs / interventionsibrutinib, acalabrutinib, zanubrutinib
Locations19 sites (Springdale, Arkansas and 18 other locations)
Trial IDNCT06524375 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of adding venetoclax to patients with chronic lymphocytic leukemia (CLL) who are already receiving a covalent Bruton's tyrosine kinase inhibitor (cBTKi) as their first-line treatment. The goal is to achieve deep durable remissions, specifically targeting undetectable measurable residual disease in the blood by the end of the combination treatment. Participants must have been on a stable dose of cBTKi for at least six months and show a partial response to the treatment. The study will evaluate whether this combination can allow patients to have an off-treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with CLL who have been on a stable dose of cBTKi for at least six months and have shown a partial response.

Not a fit: Patients who have previously received B-cell lymphoma inhibitor therapy or those with progressive disease on cBTKi may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to deeper and more durable remissions in CLL patients, potentially allowing them to avoid ongoing treatment.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies in CLL, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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. Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
3. Progressive or stable disease on cBTKi
4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
5. History of cardiomyopathy
6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
7. Clinically significant cardiovascular disease
8. Active bleeding or history of bleeding diathesis
9. Pregnant women and nursing mothers
10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Where this trial is running

Springdale, Arkansas and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Lymphocytic Leukemia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.