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

Recruiting in Palo Alto (17 mi)

Overseen byRyan Lynch

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with a certain type of lymphoma and have undergone certain treatments in the past. You are expected to survive for at least 90 days without treatment. Your liver, kidney, and blood functions are within a certain range. You are willing to comply with the study procedures and use contraception during the study and for a certain period after.

Exclusion Criteria

You have had more than one previous treatment for DLBCL or have been treated with copanlisib. You have had poor control of diabetes or have been diagnosed with HIV or hepatitis B or C. You have had any other type of cancer within the past 3 years. You have unstable heart conditions or have experienced serious bleeding or blood clotting events in the past 4 weeks. You have any other medical conditions that could affect your safety or ability to participate in the study. You are taking certain medications that may interact with the study drug.

Treatment Details

Interventions

Carboplatin (Alkylating agents)
Copanlisib (PI3K inhibitor)
Dexamethasone (Corticosteroid)
Gemcitabine (Anti-metabolites)
Rituximab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (copanlisib, R-GCD)Experimental Treatment6 Interventions

Patients receive copanlisib IV and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone PO or IV 30-60 minutes prior to chemotherapy on day 1 and PO in AM or 30-60 minutes prior to chemotherapy on days 2-4. Patients also receive pegfilgrastim 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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: