Triple drug combo targets mantle cell lymphoma

NCT ID NCT02558816

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing a combination of three drugs, obinutuzumab, ibrutinib, and GDC-0199, in people with mantle cell lymphoma. The trial includes patients whose cancer has come back or stopped responding to treatment, as well as those who have not yet received treatment. The goal is to find a safe dose and see how well the combination works.

What this could mean

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

Active substance
a three-drug combination of obinutuzumab, ibrutinib, and GDC-0199 (also known as ABT-199)
What this could lead to
If the combination works, it could offer a new treatment option for people with mantle cell lymphoma, a rare and often aggressive blood cancer.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are still uncertain. The drug combination may cause side effects that limit its use, and the results may not apply to all patients.

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

48 people

The number who actually took part.

Started

Oct 2015

Finished

May 2025

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

16 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 for French patients and Age ≥16 for UK patients * Step A + B : Relapsed / refractory MCL after at least one line of treatment. The relapse diagnosis (within 3 months before baseline), needs to be histologically confirmed (tumor biopsy or bone marrow biopsy) or confirmed by the presence (immunuphenotype) of circulating tumor cells on peripheral blood and/or bone marrow aspirate. * Step C : Untreated patients with histologically confirmed MCL (within 3 months before baseline). The initial diagnosis has to be confirmed according to WHO classification. * Stage II-IV in need of treatment * ECOG performance status of 0 - 2. * Haematology values must be within the following limits: 1. Absolute neutrophil count (ANC)≥ 1000/mm3 independent of growth factor support 2. Platelets ≥75,000/mm3 or ≥ 50,000/mm3 if bone marrow involvement and independent of transfusion support in either situation * Biochemical values within the following limits: 1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) 2. Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin 3. Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockroft Gault 11) ≥ 50 mL/min/1.73m2 * HIV, anti-HBc, HbsAg test negative * Life expectancy of more than 3 months. * Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for at least 30 days after the last dose of venetoclax or 18 months after the last dose of obinutuzumab, whichever is longer. For males, these restrictions apply for 6 months after the last dose of study drug. * Women of childbearing potential must have a negative serum or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study. * Written signed informed consent form. Non-Inclusion criteria : * 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. * Major surgery within 4 weeks of inclusion. * Known central nervous system lymphoma. * History of stroke or intracranial haemorrhage within 6 months prior to inclusion. * Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon). * Impaired liver, renal (GFR\<50ml/min) or other organ function which will interfere with the treatment. * Requires treatment with strong CYP3A inhibitors. * Vaccinated with live, attenuated vaccines within 6 months of inclusion. * Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics. (patients HbsAg+and/or antiHBc+ and/or HIV+ are excluded) * Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study treatment (ibrutinib, GA101, GDC-0199) capsules, or put the study outcomes at undue risk. * Known hypersensitivity to study treatment (GA101, Ibrutinib, GDC-0199) or to any of the excipients. * Known allergy to xanthine oxidase inhibitors and rasburicase * Severe prior reactions to monoclonal antibodies or with prior significant toxicity (other than thrombocytopenia) from Bcl-2 inhibitor * History of prior other malignancy with the exception of: Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study * Other cancers not specified above which have been curatively treated and from which subject is disease-free for \< 5 years . * Allografted patient * Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study. * Pregnancy/lactation * Men or women of reproductive potential not agreeing to use acceptable method of birth control during treatment and for 18 months after completion of treatment for the women and 6 months for the men. * Use of any standard or experimental anti-cancer drug therapy within 28 days prior to the first dose of study drug.

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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.

Contacts and locations

Locations

  • CHU Angers

    Angers, 49033, France

  • CHU Rennes

    Rennes, 35033, France

  • CHU de Dijon

    Dijon, 21000, France

  • CHU de Nantes

    Nantes, 44093, France

  • Derriford Hospital _ Plymouth Hospitals NHS Trust

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Hôpital Claude Huriez - CHRU de Lille

    Lille, 59037, France

  • Hôpital Saint Eloi

    Montpellier, 34295, France

  • Hôpital du Haut Lévêque

    Pessac, 33604, France

  • University of Southampton

    Southampton, SO16 6YD, United Kingdom

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