Triple drug combo targets mantle cell lymphoma
NCT ID NCT02558816
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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48 people
The number who actually took part.
- Started
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Oct 2015
- Finished
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May 2025
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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CHU Angers
Angers, 49033, France
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CHU Rennes
Rennes, 35033, France
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CHU de Dijon
Dijon, 21000, France
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CHU de Nantes
Nantes, 44093, France
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Derriford Hospital _ Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8DH, United Kingdom
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Hôpital Claude Huriez - CHRU de Lille
Lille, 59037, France
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Hôpital Saint Eloi
Montpellier, 34295, France
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Hôpital du Haut Lévêque
Pessac, 33604, France
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University of Southampton
Southampton, SO16 6YD, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- Which lymphoma drug combo works best? a new study aims to find out
- Can a Three-Drug combo erase mantle cell lymphoma without chemotherapy?
- Can a single injection reprogram immune cells to fight cancer?
- Can a new immune cell therapy outsmart resistant blood cancers?