Rituximab, Idelalisib, and Venetoclax in Relapsed/Refractory CLL/SLL
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- CLL
- Refractory Chronic Lymphocytic Leukemia
- Refractory Small Lymphocytic Lymphoma
- Relapsed Chronic Lymphocytic Leukemia
- Relapsed CLL
- Relapsed Small Lymphocytic Lymphoma
- SLL
- Small Lymphocytic Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Patients will start on dose level 1 of venetoclax in combination with rituximab and idelalisib, then escalate or de-escalate (if lower dose is available) based upon the estimated probabilities of toxicity from an extension of the continual reassessment method for 2 agents.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This phase 1, multicenter, dose-escalation study is designed to find the Recommended Phase 2 Dose (RP2D) of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL/SLL and to assess the clinical activity of the combination with rituximab in patients with r...
This phase 1, multicenter, dose-escalation study is designed to find the Recommended Phase 2 Dose (RP2D) of idelalisib and venetoclax in combination with rituximab in patients with relapsed or refractory CLL/SLL and to assess the clinical activity of the combination with rituximab in patients with relapsed or refractory CLL/SLL and to assess the clinical activity of the combination.
Tracking Information
- NCT #
- NCT03639324
- Collaborators
- Gilead Sciences
- Investigators
- Principal Investigator: Victor Y Yazbek, MD, MS Massey Cancer Center
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