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autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial
EU CTIS ID: 2024-511235-10-00
What this study is testing
To establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP+ibrutinib /R-DHAP followed by ASCT and ibrutinib maintenance (experimental arm A+I), and R-CHOP+ibrutinib /R-DHAP followed by ibrutinib maintenance (experimental arm I) as future standard based on the comparison of the investigator-assessed failure-free survival (FFS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically confirmed diagnosis of MCL according to WHO classification
- Sexually active men and women of child-bearing potential must agree to use one of the highly effective contraceptive methods (combined oral contraceptives using two hormones, contraceptive implants, injectables, intrauterine devices, sterilized partner) together with one of the barrier methods (latex condoms, diaphragms, contraceptive caps) while on study; this should be maintained for 90 days after the last dose of study drug and 12 months after the last dose of rituximab
- suitable for high-dose treatment including high-dose Ara-C
- Stage II-IV (Ann Arbor)
- Age ≥ 18 years and ≤ 65 years
- Previously untreated MCL
You likely can't join if
- Major surgery within 4 weeks prior to randomization.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon).
- Subjects not able to give consent
- Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Participation in another clinical trial within 30 days before randomization in this study.
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of MCL according to WHO classification
- Sexually active men and women of child-bearing potential must agree to use one of the highly effective contraceptive methods (combined oral contraceptives using two hormones, contraceptive implants, injectables, intrauterine devices, sterilized partner) together with one of the barrier methods (latex condoms, diaphragms, contraceptive caps) while on study; this should be maintained for 90 days after the last dose of study drug and 12 months after the last dose of rituximab
- suitable for high-dose treatment including high-dose Ara-C
- Stage II-IV (Ann Arbor)
- Age ≥ 18 years and ≤ 65 years
- Previously untreated MCL
- At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
- ECOG/WHO performance status ≤ 2
- The following laboratory values at screening (unless related to MCL): - Absolute neutrophil count (ANC) ≥ 1000 cells/- Platelets ≥100,000 cells/- Transaminases (AST and ALT) ≤3 x upper limit of normal (ULN) Total bilirubin Total bilirubin ≤2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome]) - Creatinine ≤ 2 mg/dL or calculated creatinine clearance ≥ 50 mL/min
- Written informed consent form according to ICH/EU GCP and national regulations
What rules you out
- Major surgery within 4 weeks prior to randomization.
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon).
- Subjects not able to give consent
- Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Participation in another clinical trial within 30 days before randomization in this study.
- History of stroke or intracranial hemorrhage within 6 months prior to randomization.
- Requires treatment with strong CYP3A4/5 inhibitors.
- 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 ibrutinib capsules, or put the study outcomes at undue risk
- Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
- Known CNS involvement of MCL
- Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
- Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound of ibrutinib itself or to the excipients in its formulation)
- Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- Serious concomitant disease interfering with a regular therapy according to the study protocol: - Cardiac (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 or LVEF below LLN ) - Pulmonary (e.g. chronic lung disease with hypoxemia) - Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus) - Renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinine clearance < 50 ml/min) - Impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2,0 mg/dl unless due to Morbus Meulengracht (Gilbert-Meulengracht-Syndrome)
- Positive test results for chronic HBV infection (defined as positive HBsAg serology) (mandatory testing) . Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBSAb) after vaccination are eligible
- Positive test results for hepatitis C (mandatory hepatitis C virus [HCV] antibody serology testing). Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
- Patients with known HIV positive infection (mandatory test)
- Prior organ, bone marrow or peripheral blood stem cell transplantation
- Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer or in situ uterine cervix cancer
- Pregnancy or lactation
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.