A Phase 3 interventional study of R-CHOP/R-DHAP and Ibrutinib (Induction) in Mantle Cell Lymphoma, sponsored by Prof. Dr. M. Dreyling (co-chairman). Recruiting at 112 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Prof. Dr. M. Dreyling (co-chairman) · Phase 3, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 870 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Prof. Dr. M. Dreyling (co-chairman) is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients must meet the following criteria:
The following laboratory values at screening (unless related to MCL):
Exclusion Criteria:
Any potential subject who meets any of the following criteria will be excluded from participating in the study.
Serious concomitant disease interfering with a regular therapy according to the study protocol:
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
Drug: R-CHOP/R-DHAP · Drug: ASCT conditioning
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)
Drug: R-CHOP/R-DHAP · Drug: Ibrutinib (Induction) · Drug: ASCT conditioning · Drug: Ibrutinib (Maintenance)
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)
Drug: R-CHOP/R-DHAP · Drug: Ibrutinib (Induction) · Drug: Ibrutinib (Maintenance)
Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)
Also known as: rituximab, CHOP, DHAP
Ibrutinib: only in cycle 1,3,5 on Day 1-19
Also known as: Imbruvica
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)
Also known as: THAM or BEAM
Ibrutinib (Maintenance), daily 560 mg for 2 years;
Also known as: Imbruvica
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.
Overall Survival
Time frame: From start of treatment until the date of first documented progression, assessed up to 120 months.
Number of participants with treatment-related adverse events as assessed by CTC Version 4.03
Safety and tolerability
Time frame: From start of Ibrutinib treatment during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints. Through study conduction, an average of up to 30 months.
Progression-free survival (PFS)
Time frame: PFS is the time to progression or death from any cause. Assed up to 120 months.
Number of Secondary Primary Malignancies
Toxicity Endpoints
Time frame: From start of treatment through the study conduction, up to 120 months.
Number of Adverse Events by CTC grade (Version 4.03)
Toxicity Endpoints
Time frame: From start of treatment through the study conduction, up to 120 months.
Showing the first 100 of 112 sites across 5 countries.
Plan to share: No
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Prof. Dr. M. Dreyling (co-chairman)