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Venetoclax, Lenalidomide, and Rituximab for Untreated Mantle Cell Lymphoma

This study is looking at a combination of three drugs – Venetoclax, Lenalidomide, and Rituximab – to see if it's safe and effective for people with Mantle Cell Lymphoma (MCL) who haven't been treated before. Researchers want to find the highest safe dose of this drug combination. You may be able to join if you are at least 18 years old, have a confirmed diagnosis of MCL, and meet certain health criteria. The study plans to enroll 28 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 28 people to find the maximum tolerated dose of the drug combination.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of finding the maximum tolerated dose is measured at 42 days, but the overall follow-up duration is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03523975

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~28 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:VenetoclaxLenalidomideRituximab

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
Measured over 42 Days

Conditions

Mantle Cell Lymphoma

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Mantle Cell Lymphoma

NCT03523975

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Medical center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohiostudy coordinator listed

    Not yet recruiting

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tycel Phillips, M.D. · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Tycel Phillips, MD
[email protected]
6263598111
Email the study team

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Eligibility criteria

Inclusion

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

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.
Psychiatric illness or social situations that would limit compliance with study requirements
Subject has known positivity to HIV
Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.
Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to\< 2 years.

What this trial measures

  • Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab42 Days