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New drug combo aims to keep mantle cell lymphoma in check

NCT ID NCT02896582

Disease control Sponsor: The Lymphoma Academic Research Organisation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding the targeted drug obinutuzumab to standard chemotherapy (DHAP) and stem cell transplant could better control mantle cell lymphoma in 86 previously untreated patients. Participants received obinutuzumab during induction, before transplant, and as maintenance for up to 3 years. The main goal was to see if the cancer could be cleared at a molecular level in the bone marrow after initial treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Obinutuzumab (a targeted antibody drug) given with chemotherapy (DHAP, BEAM) and followed by stem cell transplant and maintenance therapy.
What this could lead to
If successful, this approach could improve long-term control of mantle cell lymphoma and reduce the chance of the cancer coming back.
What could go wrong
This is a small, early-phase trial (86 people) with no comparison group, so results may not apply broadly. The treatment involves strong chemotherapy and transplant, which carry serious side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

86 people

The number who actually took part.

Started

Nov 2016

Finished

Dec 2024

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 to 65 years

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 and age ≤ 65 * Histologically confirmed (according to the World Health Organization (WHO) classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation. * Bone marrow aspiration performed at inclusion for MRD analyses * Eligible for autologous stem cell transplant * Previously untreated MCL * Stage Ann Arbor II-IV in need of treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 * Life expectancy of more than 3 months * Written informed consent * Patient affiliated by any social security system Exclusion Criteria: * Severe cardiac disease: York Heart Association (NYHA) grade 3-4 * Impaired liver (ALanine Amino Transferase (ALAT)/ASparagin Amino Transferase (ASAT) ≥ 2.5 Upper Limit of Normal (ULN), bilirubin ≥ 1.5 ULN), renal (calculated creatinine clearance \< 50 ml/min) or other organ function which will interfere with the treatment, if not related to lymphoma. * History of chronic liver disease * Hepatic veno-occlusive disease or sinusoidal obstruction syndrome * Any of the following laboratory abnormalities, if not result of a BM infiltration: * Absolute Neutrophils Count (ANC) \<1,500 /mm3 (1.5 x 109/L) * Platelet counts \< 75,000/mm3 (75 x 109/L) * Pregnancy/Nursing mothers * Fertile men or women of childbearing potential unless: * surgically sterile or ≥ 2 years after the onset of menopause * willing to use a highly effective contraceptive method * Patients with a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment. Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. * Known seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or other active infection uncontrolled by treatment. * Viral infection with hepatitis B virus (HBV) defined as hepatitis B surface antigen (HBsAg) positive and/or Hepatitis B core antibody (anti-HBc) positive Note: Patients who are immune due to hepatitis B vaccination or natural infection (HBs Ag and anti-HBc negative, anti-HBs positive) are eligible. But the patients who are immune due to hepatitis B natural infection should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation * Prior history of Progressive Multifocal Leukoencephalopathy (PML) * Vaccination with a live vaccine a minimum of 28 days prior to inclusion (Prolonged B cell depletion) * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products * Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study. * Person deprived of his/her liberty by a judicial or administrative decision * Person hospitalized without consent * Adult person under legal protection

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mantle cell lymphoma

Contacts and locations

Locations

  • APHP - Hopital Necker

    Paris, 75743, France

  • CH Perpignan

    Perpignan, 66046, France

  • CH d'Avignon

    Avignon, 84902, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHRU Bretonneau

    Tours, 37044, France

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037, France

  • CHU Limoges

    Limoges, 87042, France

  • CHU Lyon Sud

    Pierre-Bénite, 69130, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU Robert Debré

    Reims, 51092, France

  • CHU d'Amiens

    Amiens, 80480, France

  • CHU d'Angers

    Angers, 49000, France

  • CHU de Brabois

    Vandœuvre-lès-Nancy, France

  • CHU de Caen

    Caen, 14033, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63000, France

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21034, France

  • CHU de Grenoble

    Grenoble, 38700, France

  • CHU de Haut Leveque

    Pessac, 33604, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • CHU de Strasbourg

    Strasbourg, 67091, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Annecy-Genevois

    Pringy, 74374, France

  • Clinique Victor Hugo

    Le Mans, 72000, France

  • Gustave Roussy Cancer Campus

    Villejuif, 94805, France

  • Hopital Henri Mondor

    Créteil, 94010, France

  • Hôpital Saint Louis

    Paris, 75475, France

  • I.U.C.T Oncopole

    Toulouse, 31100, France

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271, France

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