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PI3K inhibitor

Copanlisib for Mantle Cell Lymphoma

Phase 1 & 2

Waitlist Available

Led By Connie Batlevi, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer 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 2 years

Awards & highlights

Study Summary

This trial is testing the safety and efficacy of combining two drugs, copanlisib and ibrutinib, to treat mantle cell lymphoma. This is the first time these drugs have been given together, and side effects are possible.

Eligible Conditions

Mantle Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete Response

Trial Design

1Treatment groups

Experimental Treatment

Group I: Copanlisib and IbrutinibExperimental Treatment2 Interventions

Copanlisib is given intravenously on days 1, 8, and 15 of 28 day cycles. Ibrutinib is given orally every day on 28 days cycles. The maximum duration of treatment is 36 cycles not exceeding 36 months. In the phase II study, the cohort will expand and accrue patients at the recommended phase II dose of copanlisib and ibrutinib determined during phase I dose escalation. In a simon two stage mini-max design, an initial 18 patients will be enrolled, inclusive of 6 patients treated at MTD or RP2D from phase I study, in first stage.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copanlisib

2016

Completed Phase 2

~130

Ibrutinib

2014

Completed Phase 3

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,890 Total Patients Enrolled

BayerIndustry Sponsor

2,240 Previous Clinical Trials

25,332,769 Total Patients Enrolled

Connie Batlevi, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what forms of treatment is Copanlisib typically utilized?

"Copanlisib is the go-to therapeutic procedure for many conditions, particularly lymphoma and follicular or mantle cell lymphomas. In addition, it has been known to help with Waldenstrom macroglobulinemia."

Answered by AI

Are recruitment efforts for this research project currently underway?

"Unfortunately, data on clinicaltrials.gov reveals that this investigation has stopped recruiting participants; the trial was first posted in March 2019 and last updated in April 2022. However, there are 1,904 other medical studies now open to enrollment."

Answered by AI

What is the sample size of this investigative trial?

"Unfortunately, this specific trial is not currently open for enrollment. It was initially posted on 13th March 2019 and underwent its last update 14th April 2022. There are presently 1720 trials concerning lymphoma that are recruiting patients as well as 184 trials involving Copanlisib which need participants."

Answered by AI

Could you please divulge any other trials that have assessed the efficacy of Copanlisib?

"In 2011, Copanlisib was first researched at National Institutes of Health Clinical Center in Rockville Pike. Since then, 116 trials have been completed and 184 live studies are currently taking place - a significant portion of which can be found within Commack, New jersey."

Answered by AI

What is the current breadth of medical centers conducting this research experiment?

"There are 6 trial sites which participants can choose from, such as the locations in Commack, Basking Ridge and Harrison. In addition to these places there are 3 other available spots."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

2019. "A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03877055.