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A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

NCT03877055 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-12-14

Study results available
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Summary

The purpose of this study is to test the safety and any good and bad side effects of combining 2 study drugs, copanlisib and ibrutinib. This combination of drugs could shrink your Mantle Cell Lymphoma (MCL), but it could also cause side effects. Both these drugs have been given to people before, but this is the first time that they are being given together.

Conditions

  • Mantle Cell Lymphoma (MCL)

Interventions

DRUG

Copanlisib

Treatment will be with intravenous copanlisib on days 1, 8, 15 of 28 day cycles.

DRUG

Ibrutinib

Oral ibrutinib daily in 28 day cycles. A cycle is defined as 28 days of therapy.

Sponsors & Collaborators

Principal Investigators

  • Connie Batlevi, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2022-10-07
Completion
2022-10-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877055 on ClinicalTrials.gov