ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

Sponsor
Prof. Dr. M. Dreyling (co-chairman)
Study ID
NCT02858258
Phase
PHASE3
Status
Unknown

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • R-CHOP/R-DHAP — DRUG
    Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)
  • Ibrutinib (Induction) — DRUG
    Ibrutinib: only in cycle 1,3,5 on Day 1-19
  • ASCT conditioning — DRUG
    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) — DRUG
    Ibrutinib (Maintenance), daily 560 mg for 2 years;

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Dec 2017
Primary completion
May 31, 2021
Completion
May 31, 2026

Study Design

Enrollment
870 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Arm A
    R-CHOP/R-DHAP: Alternating 3 cycles of R-CHOP in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM
  • Experimental: Experimental Arm A+I
    R-CHOP+Ibrutinib/R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days 1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) ASCT conditioning (ASCT: autologous stemm cell transplantation) Drug: THAM or BEAM 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenace)
  • Experimental: Experimental Arm I
    R-CHOP+Ibrutinib / R-DHAP: Alternating 3 cycles of R-CHOP + Ibrutinib at Days1-19 in cycle 1,3,5 and 3 cyles of R-DHAP in cycle 2,4,6; each 21 day cycle Drug: R-CHOP/R-DHAP Drug: Ibrutinib (Induction) 2 years Ibrutinib Maintenance Drug: Ibrutinib (Maintenance)

Primary Outcome Measure

Failure Free Survival [ Time Frame: From start of treatment until stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause, whichever comes first, assessed up to 120 months. ]

Central Contacts

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