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PI3K inhibitor

Copanlisib + Venetoclax for Mantle Cell Lymphoma

Phase 1 & 2
Waitlist Available
Led By Alexey Danilov
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing copanlisib and venetoclax as a treatment for mantle cell lymphoma. Copanlisib blocks enzymes needed for cell growth, and venetoclax blocks a protein needed for cancer cell survival.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as infections, liver problems indicated by changes in certain blood tests, fatigue from anemia or other blood-related issues, nausea due to digestive system impact, and possibly increased risk of bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of dose limiting toxicities (Phase I)
Overall response rate (Phase II)
Secondary study objectives
Duration of response
Incidence of adverse events
Overall survival
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,534 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,136 Total Patients Enrolled
Alexey DanilovPrincipal InvestigatorCity of Hope Medical Cneter
2 Previous Clinical Trials
22 Total Patients Enrolled

Media Library

Copanlisib Hydrochloride (PI3K inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04939272 — Phase 1 & 2
Mantle Cell Lymphoma Research Study Groups: Treatment (copanlisib hydrochloride, venetoclax)
Mantle Cell Lymphoma Clinical Trial 2023: Copanlisib Hydrochloride Highlights & Side Effects. Trial Name: NCT04939272 — Phase 1 & 2
Copanlisib Hydrochloride (PI3K inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04939272 — Phase 1 & 2
~0 spots leftby Nov 2024