NCT04156828

Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma

A Phase I Study Evaluating Copanlisib in Combination With R-GCD (Gemcitabine, Carboplatin, Dexamethasone, and Rituximab) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Risk Follicular Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine, carboplatin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.

Detailed description

OUTLINE: This is a dose-escalation study of copanlisib. Patients receive copanlisib intravenously (IV) and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone orally (PO) or IV 30-60 minutes prior to chemotherapy on day 1 or PO in the morning (AM) and 30-60 minutes prior to chemotherapy on days 2-4. Patients also receive pegfilgrastim subcutaneously (SC) on day 8 or 9. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 1 year.

Conditions

• Grade 3b Follicular Lymphoma
• Recurrent Diffuse Large B-Cell Lymphoma
• Recurrent Follicular Lymphoma
• Refractory Diffuse Large B-Cell Lymphoma
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Copanlisib	Given IV
DRUG	Gemcitabine	Given IV
DRUG	Carboplatin	Given IV
DRUG	Dexamethasone	Given PO
BIOLOGICAL	Rituximab	Given IV
BIOLOGICAL	Pegfilgrastim	Given SC

Timeline

• Start date: 2020-03-31
• Primary completion: 2022-04-27
• Completion: 2023-06-08
• First posted: 2019-11-08
• Last updated: 2023-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study