Loading clinical trials...

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Phase I/II Clinical Trial of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

NCT03877055•Memorial Sloan Kettering Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is ≥ 18 years of age at the time of signing Informed Consent
•Patient is able and willing to adhere to the study visit schedule and other protocol requirements
•Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma who has received at least 1 line of therapy
•°Autologous stem cell transplant recipients must have adequate bone marrow recovery and transfusion independent
•Patients may have been previously treated with BTK or PI3K inhibitors:
•°If BTK/P13K inhibitors were part of their last treatment, patients must have had a best response of stable disease or better
•Patient has at least one measurable lesion (≥ 2 cm) according to RECIL criteria\[37\]
•Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
•Patient has adequate bone marrow and organ function by:
•* Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L , independent of growth factor support for 14 days unless there is bone marrow involvement. For patients with bone marrow involvement, ANC ≥ 500/uL independent of growth factor support for 14 days
+9 more criteria

Exclusion Criteria

•Patient has a history of non-compliance to medical regimen or inability to grant consent
•Patient is concurrently using other approved or investigational antineoplastic agent with the exception of BTK or Pi3K inhibitors in patients who had these agents as the last line of treatment
•°Patient on BTK or P13K inhibitors will be continued on therapy as they transition to protocol therapy
•Patient has not recovered to Grade 1 or better (except alopecia) from related side effects of any prior antineoplastic therapy
•Patient has had major surgery or a wound that has not fully healed within 4 weeks of starting study drugs.
•Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
•Patients who have undergone an allogenic hematopoietic stem cell transplant
•Patient has active or history of central nervous system (CNS) disease or meningeal involvement.
•Patient has history of clinically significant interstitial lung disease and/or lung disease that severely impairs lung function (as judged by the investigator)
•Patient has history of stroke or intracranial hemorrhage ≤ 6 months from starting study drugs.
+10 more criteria

Locations (6)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

March 13, 2019

Primary Completion Date

October 7, 2022

Completion Date

October 7, 2022

Last Updated

December 14, 2022

Enrollment

ACTUAL participants

Conditions

Mantle Cell Lymphoma (MCL)

Interventions

Copanlisib

DRUG

Ibrutinib

DRUG

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

NCT06043011

Chronic Lymphocytic Leukemia (CLL)Diffuse Large B-cell Lymphoma (DLBCL)+4 more

View study

RECRUITINGPHASE1

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

NCT05098613

Non-Hodgkin LymphomaB-cell Non-Hodgkin Lymphoma (B-NHL)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease

Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

DALY II USA/ MB-CART2019.1 for DLBCL