2024-511235-10-00
Active, not recruiting
Phase 3
TRIANGLE - autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European mcl network trial
Klinikum der Universitaet Muenchen AöR142 sites in 10 countries832 target enrollmentStarted: November 8, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Klinikum der Universitaet Muenchen AöR
- Enrollment
- 832
- Locations
- 142
- Primary Endpoint
- FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
Overview
Brief Summary
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).
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
Secondary Outcomes
- Overall survival (OS)
- Progression-free survival (PFS) from randomization, from end of induction immuno-chemotherapy in patients with CR or PR at end of induction immuno-chemotherapy, and from the staging 6 weeks after end of induction assessment (at month 6)
- Overall response and complete remission rates at midterm, at end of induction, 3 months after end of induction immunochemotherapy (at month 6)
- PR to CR conversion rate during follow-up after end of induction immuno-chemotherapy
- Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy
- Cumulative incidence rates of SPMs
Investigators
Martin Dreyling
Scientific
Klinikum der Universitaet Muenchen AöR
Study Sites (142)
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