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Brain cancer hope: new drug cocktail targets rare lymphoma

NCT ID NCT04446962

Disease control Sponsor: Institut Curie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding lenalidomide or ibrutinib to standard chemotherapy (R-MPV) can improve outcomes for adults aged 18-65 with newly diagnosed primary central nervous system lymphoma. The trial has two parts: first, finding the safest dose, then randomly assigning patients to one of the two drug combinations. The goal is to see if more patients achieve complete remission after four cycles of treatment.

What this could mean

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

Active substance
lenalidomide (Revlimid) and ibrutinib (Imbruvica)
What this could lead to
If successful, this could improve the chance of complete remission for people with a rare brain lymphoma, potentially leading to a more effective first treatment.
What could go wrong
This is an early-phase trial (phase 1b/2) with a small number of participants, so results may not apply broadly. The drugs can cause serious side effects like infections or blood clots.

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 118 people

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

Started

Oct 2020

Expected to finish

Aug 2035

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 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: 1. Newly diagnosed Primary Central Nervous System Lymphoma (PCNSL). 2. a) Aged between 18 and 60 (\>18 and \< 60) - phase IB b) Aged between 18 and 65 (≥ 18 and ≤ 65) - phase II. 3. Histological confirmed diagnosis of Primary central nervous system lymphoma of Diffuse Large B-Cell Lymphomas (DLBCL) type OR patients with a measurable typical cerebral lesion on MRI with a diagnosis made by cytology and/or by flow cytometry on the vitreous or on the cerebral spinal fluid. 4. Measurable lesion on MRI with gadolinium enhancement. 5. Adequate hematological, renal and hepatic function (Laboratory Parameters realized within 14 days before inclusion): 1. Absolute neutrophil count (ANC) \>1000/mm3 2. Platelets \> 100,000/mm3 independent of transfusion support 3. Alanine aminotransferase and aspartate aminotransferase ≤ 3 x Upper Limit of Normal (ULN) 4. Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin 5. Estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73m2. 6. Able to swallow capsules. 7. Karnofsky performance status: 40-100% for the phase IB and no restriction on the KPS for the phase II. 8. Able to understand teratogenic risks of the Lenalidomide and Ibrutinib. Patient must be able to understand and fulfill the Lenalidomide Pregnancy Prevention Plan requirements. This plan may be accepted by the person of confidence in case of impaired cognitive status of the patient. 9. Women of childbearing potential (WCBP)\* and men who are sexually active must be practicing a highly effective method\*\* of birth control. Women should avoid a pregnancy while taking treatment by Lenalidomide or Ibrutinib and for up to 1 month after ending treatment. Men must agree to not to father a child or donate sperm during treatment by Lenalidomide or Ibrutinib and up to 3 months after the last dose of study drug. 10. Women of childbearing potential (WCBP)\* must have a negative serum (beta-human chorionic gonadotropin \[B-hCG\]) or urine pregnancy test at inclusion. 11. Signed informed consent, which could be signed by a person on confidence in case the neurologic status of the patient does not allow him to understand and/or to sign. Exclusion Criteria: 1. Histology other than DLBCL. 2. Positive HIV serology. 3. Active viral infection with Hepatitis B or C virus. 4. Preexisting immunodeficiency and/or organ transplant recipient. 5. Isolated Central Nervous System (CNS) relapse of systemic Non-Hodgkin's Lymphoma. 6. Prior treatment for PCNSL (except corticosteroids). 7. Isolated primary vitreo-retinal lymphoma. 8. Major surgery, within 4 weeks prior to the first dose of study drug. Stereotactic biopsy and vitrectomy are not considered major surgery. 9. History of stroke or intracranial hemorrhage (except minor post biopsy hemorrhage) within 6 months prior to inclusion. 10. Requires anticoagulation with warfarin or equivalent vitamin K antagonists. 11. Requires treatment with strong CYP3A4 inhibitors. 12. Pregnancy or lactation. 13. Clinically significant cardiovascular disease. 14. Any other active malignancy, except basocellular carcinoma and non-invasive cervix cancer. 15. Inclusion in another experimental anti-cancer drug therapy. 16. No social security affiliation. 17. Persons under legal protection.

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Conditions

The condition(s) this trial relates to.

central nervous system cancer central nervous system neoplasm diffuse large B-cell lymphoma lymphoma Neurologic Manifestations primary central nervous system lymphoma

As listed by the trial registrant

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

Central nervous system neoplasms, primary Lymphoma, large B-cell, diffuse

Contacts and locations

Locations

  • CH Colmar

    Colmar, France

  • CH côte Basque

    Bayonne, 64100, France

  • CHRU Lille

    Lille, 69000, France

  • CHU Amiens

    Amiens, France

  • CHU Angers

    Angers, France

  • CHU Besançon

    Besançon, France

  • CHU Caen

    Caen, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Créteil

    Créteil, France

  • CHU Dijon

    Dijon, France

  • CHU Grenoble

    Grenoble, France

  • CHU La Timone Marseille

    Marseille, France

  • CHU Limoges

    Limoges, France

  • CHU Lyon

    Lyon, France

  • CHU Nancy

    Nancy, France

  • CHU Nantes

    Nantes, France

  • CHU Nîmes - Carémeau

    Nîmes, 30029, France

  • CHU Pitié-Salpêtrière

    Paris, 75013, France

  • CHU Poitiers

    Poitiers, France

  • CHU Rennes

    Rennes, 35000, France

  • CHU Strasbourg-Hôpital Hautepierre

    Strasbourg, 67098, France

  • CHU Tours

    Tours, France

  • Centre Henri Becquerel

    Rouen, 76000, France

  • Centre Lacassagne

    Nice, France

  • Hôpital Cochin

    Paris, 75006, France

  • IUCT -Oncopole

    Toulouse, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Curie

    Paris, 75005, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.