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About
The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.
Full description
Objectives and Endpoints
Primary Objective:
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).
Secondary Objectives:
Primary Endpoint:
FFS defined as time from start of treatment to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
Secondary Efficacy Endpoints:
Secondary Toxicity Endpoints:
Exploratory Objectives:
Exploratory Endpoints:
Exploratory objectives may be evaluated only in a subset of patients according to local standards and resources.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All patients must meet the following criteria:
Histologically confirmed diagnosis of MCL according to WHO classification
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):
Written informed consent form according to ICH/EU GCP and national regulations
Sexually active men and women of child-bearing potential must agree to use highly effective contraceptives (eg, condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.
Exclusion criteria
Any potential subject who meets any of the following criteria will be excluded from participating in the study.
Major surgery within 4 weeks prior to randomization.
Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg phenprocoumon).
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
Clinically significant hypersensitivity (eg, 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
Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol
Serious concomitant disease interfering with a regular therapy according to the study protocol:
Patients with unresolved hepatitis B or C infection or 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
Any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule
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.
Primary purpose
Allocation
Interventional model
Masking
870 participants in 3 patient groups
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Central trial contact
Döndü Gözel; Christian Schmidt, Dr.
Data sourced from clinicaltrials.gov
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