Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 37
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Recurrent Diffuse Large B-Cell Lymphoma
- Refractory Diffuse Large B Cell Lymphoma
- Richter Syndrome
- Small Lymphocytic Lymphoma
- Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
- Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma
- Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell 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 OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) of duvelisib in combination with nivolumab for patients with Richter?s syndrome or transformed follicular lymphoma. SECONDARY OBJECTIVES: I. To assess preliminary efficacy of duvelisib in combination with nivolumab in Richter?s syn...
PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) of duvelisib in combination with nivolumab for patients with Richter?s syndrome or transformed follicular lymphoma. SECONDARY OBJECTIVES: I. To assess preliminary efficacy of duvelisib in combination with nivolumab in Richter?s syndrome and transformed follicular lymphoma (overall response rate, progression free survival, overall survival). II. To determine the toxicity profile of duvelisib in combination with nivolumab. EXPLORATORY OBJECTIVES: I. To correlate response to duvelisib in combination with nivolumab with cytogenetic/fluorescence in-situ hybridization (FISH) abnormalities of the chronic lymphocytic leukemia (CLL) and lymphoma compartments (for patients with Richter?s syndrome) at baseline. II. To correlate response to duvelisib in combination with nivolumab with baseline deoxyribonucleic acid (DNA) mutation of CLL and lymphoma as assessed in tumor samples and cell free DNA. III. To determine changes in T, B, and natural killer (NK) cell number and function during duvelisib plus nivolumab therapy. OUTLINE: This is a dose-escalation study of duvelisib. Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
Tracking Information
- NCT #
- NCT03892044
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jennifer A Woyach, MD Ohio State University Comprehensive Cancer Center