IRB #

STUDY00018655

Title

A Phase I Study of PI3Kα,δ Inhibitor Copanlisib in Combination with PD-1 Antagonist Nivolumab in Patients with Transformed Chronic Lymphocytic Leukemia (Richter’s Transformation) or Non-Hodgkin Lymphoma

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of this study is to find out what effects, good or bad, treatment with copanlisib in combination with nivolumab has on people with transformed chronic lymphocytic leukemia (Richter’s transformation) or indolent non-Hodgkin’s lymphoma (NHL) into an aggressive lymphoma sub-type (diffuse large B-cell lymphoma; DLBCL).

Medical Condition(s)

Relapsed or refractory Richter's transformation or transformed NHL (such as DLBCL)

Eligibility Criteria

- Men and women at least 18 years of age.
- Diagnosis of Richter's transformation (transformed CLL), or indolent NHL (FL, LPL, MZL) in transformation. Only patients who have DLBCL histology are eligible.
- Participants with RS must have received at least 2 cycles of prior systemic therapy for either RS and underlying CLL.
- Participants with transformed FL must not be candidates for autologous stem cell transplant, or have relapsed following autologous stem cell transplant which took place at least 3 months prior to study therapy.
- No prior therapy with nivolumab or pembrolizumab.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the study drugs for a total of 48 weeks of therapy (12 cycles). After participants finish the study treatment, the investigator will continue to watch participants for side effects and follow participants until disease progression or death (whichever occurs earlier).

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Oregon Health & Science University, with funding from Bayer Healthcare Pharmaceuticals, LLC, and Bristol-Myers Squibb

Recruitment End

01/01/2023

Compensation Provided

No


Go Back