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Triple-Drug attack on rare lymphoma shows early promise

NCT ID NCT03523975

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2018

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Locations

  • City of Hope Medical center

    RECRUITING

    Duarte, California, 91010, United States

  • The Ohio State University Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

    Contact Email: •••••@•••••

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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