At a glance
ClinicalIndex Comparison Record- ✓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 18-65 years
- ✕Major surgery within 4 weeks prior to randomization
- ✕Requires anticoagulation with warfarin or vitamin K antagonists
- ✕History of stroke or intracranial hemorrhage within 6 months
- ✕Requires strong CYP3A4/5 inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT02858258Phase 3RecruitingUpdate OverdueUpdated 102mo ago · Completion was 62mo agoAutologous Transplantation After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma - a Randomized European Mcl Network Trial
In Brief
A Phase 3 clinical trial evaluating R-CHOP/R-DHAP, Ibrutinib (Induction), and 2 other interventions for Mantle Cell Lymphoma. Currently recruiting, targeting 870 participants across 112 sites in 5 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)
Ibrutinib: only in cycle 1,3,5 on Day 1-19
ASCT conditioning THAM or BEAM, stratified per site before trial activation at site THAM (TBI (total body irradiation), Ara-C, Melphalan) or BEAM (BCNU, Etoposide, Cytarabine, Melphalan)
Ibrutinib (Maintenance), daily 560 mg for 2 years;