NL-OMON23205
Recruiting
Not Applicable
A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of obinutuzumab (Gazyvaro) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens
HOVON data center0 sites70 target enrollmentTBD
ConditionsChronic Lymphocytic Leukemia (CLL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Sponsor
- HOVON data center
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of symptomatic CLL (according to IWCLL guidelines, including minimal required markers (CD5/CD19/CD23 triple positive with light chain restriction))
- •Patients without prior treatment for CLL (Corticoid treatment administered due to necessary immediate intervention is allowed; within the last 10 days before start of study treatment only dose equivalents of maximum 20 mg prednisolone are permitted);
Exclusion Criteria
- •♦ Current inclusion in other clinical trials
- •♦ Intolerance of exogenous protein administration;
Outcomes
Primary Outcomes
Not specified
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