A prospective, multicenter, phase-II trial of ibrutinib plus venetoclax in patients with creatinine clearance >= 30 ml/min who have relapsed or refractory chronic lymphocytic leukemia (RR-CLL) with or without TP53 aberrations
Phase 2
Completed
- Conditions
- <p>Chronic Lymfocytic Leukemia (CLL)</p>CLL10024324
- Registration Number
- NL-OMON23972
- Lead Sponsor
- HOVON Data Center
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
? Documented CLL or SLL requiring treatment according to IWCLL criteria after either being refractory to first line therapy or relapse after initial therapy.
? Age at least 18 years.
Exclusion Criteria
? Any prior therapy with ibrutinib and/or venetoclax.
? Transformation of CLL (Richter¡¯s transformation).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(Only considered for arm B of the study)<br /><br>- Proportion of patients fulfilling the criteria for progression free survival (PFS) at 12 months after stopping therapy (27 months after starting treatment) for patients randomized to stop treatment (arm B of the study), reinitiated treatment due to MRD positivity not considered progression (see section 13.1 for details).</p><br>
- Secondary Outcome Measures
Name Time Method