Combination treatment for untreated Mantle Cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of an experimental treatment combining venetoclax, lenalidomide, and rituximab for patients diagnosed with Mantle Cell Lymphoma (MCL). Participants must be at least 18 years old and have a confirmed diagnosis of MCL, with specific health criteria to ensure eligibility. The study aims to assess how well this combination therapy works compared to standard treatments. It involves monitoring participants for side effects and overall response to the treatment.

Why it matters

Who can join: the full rules

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.
* 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.

Where it's running

• City of Hope Medical center
  Duarte, California, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• University of Virginia Cancer Center
  Charlottesville, Virginia, United States Recruiting
• The Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Not yet recruiting

Study contacts

• Principal investigator: Tycel Phillips, M.D. — City of Hope Medical Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Bendamustine–Rituximab–Cytarabine plus Zanubrutinib induction followed by zanubrutinib/rituximab with or without sonrotoclax maintenance for newly diagnosed mantle cell lymphoma

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• Combination treatment for chronic lymphocytic leukemia and lymphoma

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• Combining nemtabrutinib and rituximab to treat mantle cell lymphoma

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• CAR-T-cell treatment for high-risk mantle cell lymphoma

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  Recruiting at 2 sites Phase 2 Ludwig-Maximilians - University of Munich · Mainz and 1 other locations · NCT06482684

• Comparing Orelabrutinib with standard treatment for mantle cell lymphoma

  This study is testing if adding a new drug called Orelabrutinib to the standard treatment can help older patients with untreated mantle cell lymphoma feel better and improve their outcomes.

  Recruiting at 19 sites Phase 3 InnoCare Pharma Inc. · Beijing and 38 other locations · NCT06363994

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.