CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Indolent B-Cell Non-Hodgkin Lymphoma
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Chronic Lymphocytic Leukemia
- Refractory Marginal Zone Lymphoma
- Refractory Hairy Cell Leukemia
- Recurrent Follicular Lymphoma
- Recurrent Hairy Cell Leukemia
- Refractory Lymphoplasmacytic Lymphoma
- Refractory Mantle Cell Lymphoma
- Refractory Mucosa-Associated Lymphoid Tissue Lymphoma
- Recurrent Lymphoplasmacytic Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Refractory Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Recurrent Mucosa-Associated Lymphoid Tissue Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Follicular Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: To assess the safety and toxicity of oral azacitidine (CC-486) in combination with lenalidomide and obinutuzumab. SECONDARY OBJECTIVES: I. To evaluate the efficacy of CC-486 in combination with lenalidomide and obinutuzumab in subjects with relapsed/refractory indolent B-cell lymp...
PRIMARY OBJECTIVE: To assess the safety and toxicity of oral azacitidine (CC-486) in combination with lenalidomide and obinutuzumab. SECONDARY OBJECTIVES: I. To evaluate the efficacy of CC-486 in combination with lenalidomide and obinutuzumab in subjects with relapsed/refractory indolent B-cell lymphoma as assessed by: Ia. Overall response rate: complete response (CR) + partial response (PR) per 2016 Lugano criteria and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) criteria. Ib. Duration of response (DOR): will be calculated from time of initial response assessment demonstrating at least PR until disease response assessment that demonstrates progressive disease. Ic. Time to response (TTR): calculated as time from registration to first disease response assessment that demonstrates at least PR. Id. Progression-free survival (PFS): Patients are considered a failure for this endpoint if they die or if they relapse/progress or receive additional anti-lymphoma therapy. Ie. Determine the recommended phase 2 dose (RP2D).
Tracking Information
- NCT #
- NCT04578600
- Collaborators
- National Cancer Institute (NCI)
- Celgene
- Investigators
- Principal Investigator: Joseph M Tuscano University of California, Davis