Recruitment

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
  • Recurrent Follicular Lymphoma
  • Recurrent Hairy Cell Leukemia
  • Recurrent Lymphoplasmacytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Refractory Lymphoplasmacytic Lymphoma
  • Refractory Marginal Zone Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Recurrent Mucosa-Associated Lymphoid Tissue Lymphoma
  • Refractory Hairy Cell Leukemia
  • Refractory Mucosa-Associated Lymphoid Tissue Lymphoma
  • Refractory Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory 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