Copanlisib + Venetoclax for Mantle Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByAlexey Danilov

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects, best dose, and effectiveness of copanlisib and venetoclax in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving copanlisib and venetoclax may help treat patients with mantle cell lymphoma.

Eligibility Criteria

This trial is for adults with mantle cell lymphoma that has returned or isn't responding to treatment. Participants must be able to take pills, have a life expectancy of at least 3 months, and proper organ function. They should not have HIV, hepatitis B or C, uncontrolled diseases like diabetes or heart conditions, and women must not be pregnant.

Participant Groups

The trial is testing the combination of two drugs: Copanlisib Hydrochloride and Venetoclax. It aims to find the safest doses and see how effective they are against relapsed or refractory mantle cell lymphoma by blocking enzymes and proteins cancer cells need to grow.

1Treatment groups

Experimental Treatment

Group I: Treatment (copanlisib hydrochloride, venetoclax)Experimental Treatment2 Interventions

Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15, and venetoclax PO QD on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Copanlisib will be given at 30mg, 45mg, or 60 mg depending on the assigned dose level. Venetoclax will have a weekly dose ramp up from 20mg, 50mg, 100mg, 200mg, and then 400mg thereafter.