Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- David Bond, MD
- Study ID
- NCT03892044
- Phase
- PHASE1
- Status
- Completed
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
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Duvelisib — DRUGGiven PO
- Nivolumab — BIOLOGICALGiven IV
Study Details
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.
Key Dates
- Start date
- Nov 5, 2019
- Status verified
- Apr 2024
- Primary completion
- Feb 14, 2024
- Completion
- Feb 14, 2024
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (duvelisib, nivolumab)Patients receive duvelisib PO BID on days 1-28 and nivolumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Maximum-tolerated dose (MTD) of duvelisib [ Time Frame: Up to 28 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | - |
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