Combining Venetoclax, Rituximab, and Ibrutinib for Treating Chronic Lymphocytic Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multicenter, open-label interventional study evaluates the effectiveness of adding ibrutinib to a 12-month treatment regimen of venetoclax and rituximab in patients with treatment-naïve Chronic Lymphocytic Leukemia (CLL) who have undetectable minimal residual disease (uMRD). The treatment involves an initial ramp-up of venetoclax followed by a combination with rituximab, with the goal of achieving uMRD status by the end of the treatment cycles. Patients will be monitored for their MRD status to determine the continuation or cessation of therapy based on their response. This approach aims to optimize treatment outcomes for CLL patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years but \<65 years
2. Active CLL/SLL requiring treatment per iwCLL 2018 criteria
3. No previous therapy for CLL/SLL
4. Adequate bone marrow function:

   1. ANC ≥1.0 x 109/L;
   2. Plt ≥25 x 109/L;
   3. Hgb ≥8.0 g/dl

Exclusion Criteria:

1. Any prior therapy used for treatment of CLL or SLL
2. History of other malignancies, except in situ carcinoma or malignancy treated with curative intent
3. Known or suspected history of Richter's transformation
4. Known hypersensitivity to one or more study drugs
5. Inadequate renal function: CrCl \<30 mL/min
6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
7. Requires the use of warfarin or derivatives
8. Treatment with any of the following within 7 days prior to the first dose of study drug:

   1. Steroid therapy for anti-neoplastic intent
   2. Moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix G for examples)
   3. Moderate or strong CYP3A inducers (see Appendix G for examples)

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Paolo Ghia, MD, PhD
• Email: ghia.paolo@hsr.it
• Phone: 0039022643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

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• Comparing venetoclax and rituximab to ibrutinib and rituximab for treating Waldenstrom's macroglobulinemia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.