NCT03892044

Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma

A Phase I Study of Duvelisib in Combination With Nivolumab for Patients With Richter's Syndrome and Transformed Follicular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: David Bond, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of duvelisib when given together with nivolumab in treating patients with Richter syndrome or transformed follicular lymphoma. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib and nivolumab may work better in treating patients with Richter syndrome or transformed follicular lymphoma compared to giving duvelisib or nivolumab alone.

Detailed 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 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.

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

Interventions

Type	Name	Description
DRUG	Duvelisib	Given PO
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2019-11-05
• Primary completion: 2024-02-14
• Completion: 2024-02-14
• First posted: 2019-03-27
• Last updated: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study