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Mantle Cell Lymphoma Clinical Trials and Treatments

Also called Mantle Zone Lymphoma, Mantle Cell Lymphomas, Leukemic Non-Nodal Mantle Cell Lymphoma

Mantle cell lymphoma begins in B cells from the mantle zone, the outer ring of a lymph node's follicle. Its hallmark is a swap between chromosomes 11 and 14, written t(11;14), which makes the cells overproduce cyclin D1, a protein that drives cell division.

In plain words, mantle cell lymphoma is a rare cancer of B cells, a kind of white blood cell, that usually starts in the lymph nodes. It often grows quickly and tends to come back after treatment, but many newer medicines can hold it in check.

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Mantle Cell Lymphoma

Where treatments stand, from ClinicalTrials.gov and FDA labels

FDA review0

No decision pending. FDA calendar

FDA-approved medicines8

Calquence · Brukinsa · Jaypirca · Beqalzi · Tecartus · 3 more

Mantle Cell Lymphoma has 8 FDA-approved medicines, 131 open or active clinical trials, and no pending FDA decision.

Labels checked October 21, 2026. Corticosteroids and immune globulins count once each.Download the data

More about Mantle Cell Lymphoma

A 2017 review in the American Journal of Hematology reports that cyclin D1 is found in 98% of cases, and that a missing SOX11 protein or a low Ki-67 growth score may point to a slower-growing form (Vose, 2017).

Keep reading about Mantle Cell Lymphoma

Mayo Clinic describes the classic form, which starts in the lymph nodes, as the most common type, and a leukemic non-nodal form that grows slowly and is found mainly in the blood and spleen. Rare blastoid and pleomorphic variants are more aggressive. Diagnosis rests on a lymph node or bone marrow biopsy, blood tests and CT or PET scans. Doctors estimate risk with the Mantle Cell Lymphoma International Prognostic Index (MIPI), which combines age, overall fitness, white blood cell count and LDH.

Cleveland Clinic says mantle cell lymphoma is not curable but that treatment can bring remissions lasting months or years. Treatment may combine chemotherapy and immunotherapy, BTK inhibitor pills, stem cell transplant, CAR T-cell therapy and other targeted medicines. The FDA has approved several medicines for it, including BTK inhibitors such as Brukinsa (zanubrutinib), Calquence (acalabrutinib) and Jaypirca (pirtobrutinib), the BCL-2 inhibitor Beqalzi (sonrotoclax), and the CAR T-cell therapies Tecartus and Breyanzi.

What are the symptoms of Mantle Cell Lymphoma?

These are common symptoms of Mantle Cell Lymphoma, and how strong they are varies from person to person.

  • Swollen lymph nodes in the neck, armpit or groin
  • Fatigue and weakness
  • Fever and night sweats
  • Unexplained weight loss and loss of appetite
  • Indigestion or belly symptoms when the gut is involved
  • Easy bruising

Who gets Mantle Cell Lymphoma?

The National Cancer Institute describes mantle cell lymphoma as a cancer that usually occurs in middle-aged or older adults, and Cleveland Clinic says people aged 60 to 70 have a slightly higher risk, though anyone can develop it.

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Which medicines are FDA-approved for Mantle Cell Lymphoma?

There are currently 8 FDA-approved medications for Mantle Cell Lymphoma.

acalabrutinib
AstraZeneca
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zanubrutinib
BeOne Medicines (formerly BeiGene)
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pirtobrutinib
Eli Lilly and Company
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sonrotoclax
BeOne Medicines (formerly BeiGene)
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Velcade
bortezomib
Takeda
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Revlimid
lenalidomide
Bristol Myers Squibb (Celgene)
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brexucabtagene autoleucel
Kite Pharma (Gilead)
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lisocabtagene maraleucel
Juno Therapeutics (Bristol Myers Squibb)
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

How to get help paying for Mantle Cell Lymphoma treatment

Charity funds and drugmaker programs for Mantle Cell Lymphoma, checked at the source.

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Charity funds
  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Clinical Trials Co-Pay Fund (all blood cancers) fund
    Open

    Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).

  • From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)
    Patient Aid Program fund
    Open

    Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.

    The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.”
  • From a charity · HealthWell Foundation
    Mantle Cell Lymphoma fund
    Open

    Pays for: Prescription copays; Medicare Part B premiums, up to $8,500 per year. Requires health insurance (any kind).

Status as each foundation showed it on October 26, 2026.

Every program and fund for Mantle Cell Lymphoma, by insurance →

Side effects people have reported to the FDA

Side effects people have reported to the FDA

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and genetic testing

How Mantle Cell Lymphoma is diagnosed

Not inherited. The t(11;14) swap between chromosomes 11 and 14 happens in the lymphoma cells during life, not in the genes a person is born with.

Trusted Mantle Cell Lymphoma resources

Reputable organizations and medical references for learning more about Mantle Cell Lymphoma, including disease registries, foundation resources, and clinical guidelines.

Active clinical trials for Mantle Cell Lymphoma

Use this Mantle Cell Lymphoma clinical trial finder to see the 14 studies recruiting patients and 1 opening soon in the United States and worldwide, with eligibility criteria in plain English. Of these, 14 test a treatment and 1 is an observational study or registry; each card says which. Every trial comes from ClinicalTrials.gov.

Jump to the trial list, the site map or the pipeline timeline.

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

131 active trials worldwide
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Not yet recruitingTreatment trialPhase 2Recently updatedNCT07910435

Polatuzumab Vedotin, Mosunetuzumab, and Acalabrutinib for the Treatment of Mantle Cell Lymphoma, PAcMan Trial

Intervention: Polatuzumab Vedotin, Acalabrutinib, Mosunetuzumab, Bone Marrow Biopsy, Core Biopsy, FDG-Positron Emission Tomography and Computed Tomography Scan, Neurologic Examination, Patient Observation, Biospecimen Collection, Bone Marrow Aspiration

Sponsor: University of Washington · Genentech, Inc.

This phase II trial tests how well polatuzumab vedotin, mosunetuzumab, and acalabrutinib work in treating patients with mantle cell lymphoma. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called monomethyl auristatin E. Polatuzumab is a form o...

Ages 18 Years+1 location
Expected to start Mar 2027Updated todayEst. Jan 2033 (~6y 2m)
RecruitingTreatment trialPhase 2Recently updatedNCT07003295

Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy

Intervention: Biospecimen Collection, Computed Tomography, Glofitamab, Obinutuzumab, Positron Emission Tomography

Sponsor: National Cancer Institute (NCI)

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) afte...

Ages 18 Years+11 locations
Started Jul 2026Updated todayEst. Aug 2027 (~10 months)
RecruitingTreatment trialPhase 2Recently updatedNCT06839053

Sonrotoclax, Rituximab, and Zanubrutinib in Treating Participants With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Mantle Cell Lymphoma

Intervention: Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Gastrointestinal Endoscopy, Rituximab, Sonrotoclax, Zanubrutinib

Sponsor: Fred Hutchinson Cancer Center · BeOne Medicines

This phase II trial studies the side effects of an escalated ramp-up of sonrotoclax following initial debulking with zanubrutinib or rituximab in treating patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) that is ne...

Ages 18 Years+1 location
Started Jun 2025Updated 3 days agoEst. Aug 2028 (~1y 9m)
RecruitingTreatment trialPhase 3Recently updatedNCT06742996

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Intervention: Sonrotoclax, Zanubrutinib, Placebo

Sponsor: BeOne Medicines

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Ages 18 Years+144 locations
Started Mar 2025Updated 4 days agoEst. Aug 2028 (~1y 10m)
RecruitingObservational study, no treatment givenRecently updatedNCT05724121

Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Background:

Ages 18 Years to 110 Years1 location
Started Mar 2023Updated 4 days agoEst. Apr 2027 (~5 months)
Find Mantle Cell Lymphoma trials near you, ranked by distance →
Active trial locations58 cities in the US
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Trial Pipeline

Jan 2021 to Nov 2031
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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
Always talk to your doctor before considering a clinical trial.

Mantle Cell Lymphoma patient communities

Facebook groups, Reddit communities and YouTube channels where Mantle Cell Lymphoma patients, caregivers and advocacy groups talk.

Companies developing Mantle Cell Lymphoma treatments

Drugmakers that list Mantle Cell Lymphoma in their rare disease portfolio, 1 in all.

Questions people ask about Mantle Cell Lymphoma