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New cocktail aims to wipe out mantle cell lymphoma in two years

NCT ID NCT04802590

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding venetoclax to ibrutinib and an anti-CD20 antibody can better clear minimal residual disease in people with newly diagnosed mantle cell lymphoma. About 210 patients will receive either the two-drug or three-drug combo for up to two years, plus antibody therapy for 3.5 years. The main goal is to see how many patients have no detectable cancer cells after six months.

What this could mean

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

Active substance
Ibrutinib, venetoclax, and anti-CD20 antibody
What this could lead to
If successful, this could lead to a more effective fixed-duration treatment for newly diagnosed mantle cell lymphoma, potentially reducing the need for continuous therapy.
What could go wrong
This is a phase 2 trial with 210 participants, so results are still preliminary. The combination may cause side effects like low blood counts, infections, or heart issues, and it's not yet clear if it will improve long-term outcomes.

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

210 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Mar 2030

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 to 79 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: 1. Patient is ≥ 18 years and \< 80 years of age at the time of signing the informed consent form (ICF). 2. Patient understood and voluntarily signed and dated an ICF prior to any study-specific assessments/procedures being conducted. 3. Patient willing and able to adhere to the study visit schedule and other protocol requirements 4. Women of childbearing potential must have negative results for pregnancy test prior to study treatment start and agree to abstain from breastfeeding during study participation and at least 18 months after the last drug administration 5. Men or women of reproductive potential agree to use acceptable method of birth control during treatment and for eighteen months after the last drug administration. 6. 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 (by cytogenetics and/or fluorescence in situ hybridization (FISH) and/or BCL1-IgH PCR) 7. Untreated MCL 8. Adequate renal function as demonstrated by a creatinine clearance \> 50 mL/min; calculated by Cockcroft Gault formula or Modification of Diet in Renal Disease (MDRD) 9. Adequate hepatic function per local laboratory reference range as follow: * Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x upper limit of normal (ULN) * Bilirubin \< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) 10. Stage II-IV disease, measurable with at least lymph node \> 1.5 cm and requiring treatment in the opinion of the treating clinician 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. 12. Life expectancy of more than 3 months. 13. For France: patient affiliated to any social security system Exclusion Criteria: 1. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. 2. Impaired organ function (other than liver and renal) which will interfere with the treatment 3. Hemoglobin level \< 10g/dL; Neutrophil count \<1 G/L; Platelets \< 75 G/L (except if related to lymphoma then platelet must be \>50), 4. Major surgery within 28 days before enrollment 5. Known central nervous system lymphoma 6. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 7. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) 8. Requires treatment with strong CYP3A inhibitors 9. Vaccinated with live, attenuated vaccines within 6 months of enrollment (except COVID vaccine) 10. Known history of human immunodeficiency virus (HIV) 11. Evidence of other clinically significant uncontrolled condition(s) including but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal) * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. HBs antigen negative, anti-HBs antibody + and antiHBc antibody -) and subjects with anti-HB-core antibody that are HBV DNA negative may participate 12. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study 13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator' opinion, could compromise the patient safety, interfere with the absorption or metabolism of treatment (Ibrutinib, CD20 Ab, venetoclax) or put the study outcomes at undue risk 14. Pregnant, planning to become pregnant, or lactating woman 15. Known hypersensitivity to study treatment (CD20 Ab, Ibrutinib, Venetoclax) or to any of the excipients 16. Known allergy to xanthine oxidase inhibitors or rasburicase 17. Known glucose-6-phosphate dehydrogenase (G6DP) deficiency 18. Known bleeding disorders 19. Severe prior reactions to monoclonal antibodies or with prior significant toxicity (other than thrombocytopenia) from Bcl-2 inhibitor 20. History of prior other malignancy with the exception of: * curatively treated basal cell carcinoma * curatively treated squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study * other curatively treated cancer and patient disease-free for over 5 years 21. Anti-cancer therapies including chemotherapy, radiotherapy or other investigational therapy, including targeted small molecule agents 22. Biological agents (e.g. monoclonal antibodies) for anti-neoplastic intent: excluded 30 days prior to first dose of venetoclax 23. Person deprived of his/her liberty by a judicial or administrative decision 24. 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

  • A.Z. Sint Jan AV

    Bruges, 8000, Belgium

  • CH Henri Mondor

    Créteil, 94010, France

  • CH d'Avignon - Hopital Henri Duffaut

    Avignon, 84000, France

  • CH de Bretagne Atlantique - Hopital CHUBERT

    Vannes, 56017, France

  • CH de Cornouaille

    Quimper, 29107, France

  • CH de la Côte Basque

    Bayonne, 64109, France

  • CHD de Vendée

    La Roche-sur-Yon, 85925, France

  • CHRU de Lille

    Lille, 59037, France

  • CHU Bretonneau

    Tours, 37044, France

  • CHU Jean Minioz

    Besançon, 25030, France

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • CHU Pontchaillou

    Rennes, 35033, France

  • CHU d'Angers

    Angers, 49033, France

  • CHU de DIJON

    Dijon, 21000, France

  • CHU de Grenoble

    La Tronche, 38700, France

  • CHU de Liege

    Liège, 4000, Belgium

  • CHU de Montpellier

    Montpellier, 34295, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de REIMS

    Reims, 51092, France

  • Centre Henri BECQUEREL

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Léon Bérard

    Lyon, 69373, France

  • Ch Annecy Gennevois

    Pringy, 74374, France

  • Chu Estaing

    Clermont-Ferrand, 63003, France

  • Chu de Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie

    Pessac, 33604, France

  • Chu de Brest - Hopital de La Cavale Blanche

    Brest, 29609, France

  • Hopital DUPUYTREN

    Limoges, 87042, France

  • Hopital Jolimont

    Haine-Saint-Paul, 7100, Belgium

  • Hopital NECKER

    Paris, 75743, France

  • Hopital René Huguenin

    Saint-Cloud, 92210, France

  • Hopital St-Louis

    Paris, 75475, France

  • Hopital de la Milétrie

    Poitiers, 86021, France

  • IUCT Oncopole

    Toulouse, 31100, France

  • Institut Gustave ROUSSY

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut d'Hématologie de Basse Normandie

    Caen, 14033, France

  • Institut de Cancérologie Strasbourg Europe

    Strasbourg, 67033, France

  • Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270, France

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Royal Cornwall Hospital Trust

    Truro, TR1 3LJ, United Kingdom

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Universite Catholique de Louvain Mont Godinne

    Yvoir, 5530, Belgium

  • Universite Libre de Bruxelles - Hopital ERASME

    Brussels, 1070, Belgium

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

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