Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT03884998
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Chronic Lymphocytic Leukemia
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Indolent Non-Hodgkin Lymphoma
- Lymphoplasmacytic Lymphoma
- Marginal Zone Lymphoma
- Richter Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Copanlisib — DRUGGiven IV
- Nivolumab — BIOLOGICALGiven IV
Study Details
This phase I trial studies the best dose and how well copanlisib when given together with nivolumab works in treating patients with Richter's transformation or transformed indolent non-Hodgkin lymphoma. Copanlisib 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 copanlisib and nivolumab may work better in treating patients with Richter's transformation or transformed non-Hodgkin lymphoma.
Key Dates
- Start date
- Feb 26, 2019
- Status verified
- Dec 2025
- Primary completion
- Nov 4, 2026
- Completion
- Nov 4, 2026
Study Design
- Enrollment
- 27 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (copanlisib and nivolumab)Patients receive copanlisib IV over 60 minutes on days 1, 8, and 15 and nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Incidence of dose-limiting toxicities of copanlisib in combination with nivolumab [ Time Frame: Up to day 28 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | - |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | - |
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