Triple-Drug attack on rare lymphoma shows early promise
NCT ID NCT03523975
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether a combination of three drugs—venetoclax, lenalidomide, and rituximab—is safe and effective for people with untreated mantle cell lymphoma, a rare blood cancer. About 28 adults will take these pills and infusions over several months. The goal is to find the best dose and see how many patients achieve complete remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax, lenalidomide, and rituximab (drug combination)
- What this could lead to
- If successful, this could offer a new, effective first-line treatment option for mantle cell lymphoma, potentially improving remission rates.
- What could go wrong
- This is an early-phase trial with only 28 participants, so results may not apply to all patients. The drug combination may cause significant side effects, and it's not yet known if it works better than current standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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City of Hope Medical center
RECRUITINGDuarte, California, 91010, United States
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The Ohio State University Comprehensive Cancer Center
NOT_YET_RECRUITINGColumbus, Ohio, 43210, United States
Contact Email: •••••@•••••
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Triple drug combo targets mantle cell lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- Can a single injection reprogram immune cells to fight cancer?