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Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Phase I/II Multi-site Study Evaluating the MTD, Safety and Efficacy of the Combination Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

NCT03523975•City of Hope Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years
•Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment
•Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
•ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2
•All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
•Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
•Men and Women of childbearing potential on appropriate contraception
•Adequate organ function
•Ability to understand and the willingness to sign a written informed consent.
•Ability to swallow oral capsules/tablets

Exclusion Criteria

•Prior treatment for MCL with chemotherapy
•Pregnant or breastfeeding women
•Grade 2 or higher peripheral neuropathy
•Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
•Significant cardiovascular disease
•Any condition that might significantly impair drug absorption as determined by the investigator
•Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug
•History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug
•Concurrent participation in another clinical trial
•Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.
+4 more criteria

Locations (3)

City of Hope Medical center

Duarte, California, United States

University of Michigan

Ann Arbor, Michigan, United States

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

December 24, 2018

Primary Completion Date

June 24, 2027

Completion Date

June 24, 2027

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Mantle Cell Lymphoma

Interventions

Venetoclax

DRUG

Lenalidomide

DRUG

Rituximab

DRUG

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

NCT06263491

Mantle Cell Lymphoma

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 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: March 13, 2026Data 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

Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma