Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL

Sponsor
European Mantle Cell Lymphoma Network
Study ID
NCT00209209
Phase
PHASE3
Status
Unknown

Conditions

  • Lymphoma, Mantle-Cell

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    antibody
  • Cyclophosphamide — DRUG
    chemotherapy
  • Doxorubicin — DRUG
    chemotherapy
  • Vincristine — DRUG
    chemotherapy
  • Prednisone — DRUG
    coricosteroide
  • Fludarabine — DRUG
    chemotherapy
  • Interferon-alpha — DRUG
    cytokine
  • pegylated formula Interferon-alpha 2b — DRUG
    cytokine
  • chemotherapy: R-CHOP — PROCEDURE
    immuno-chemotherapy
  • chemotherapy: R-FC — PROCEDURE
    immuno-chemotherapy
  • Interferon maintenance — PROCEDURE
    cytokine
  • Rituximab maintenance — PROCEDURE
    antibody

Study Details

The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas: * Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy? * Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?

Key Dates

Start date
Jan 14, 2004
Status verified
Mar 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

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

Arms

  • Active Comparator: 1
    1. randomisation: R-CHOP 2. randomisation: IFN maintenance
  • Experimental: 2
    1. randomisation: R-FC 2. randomisation: Rituximab maintnenance

Primary Outcome Measure

First randomisation: Reduction of lymphoma mass measured by the complete remission (CR) rate