Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL

Sponsor
European Mantle Cell Lymphoma Network
Study ID
NCT00209222
Phase
PHASE3
Status
Unknown

Conditions

  • Lymphoma, Mantle-Cell

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    antibody
  • Cyclophosphamide — DRUG
    chemotherapy
  • Doxorubicin — DRUG
    chemotherapy
  • Vincristine — DRUG
    chemotherapy
  • Prednisone — DRUG
    corticosteroide
  • Cisplatinum — DRUG
    chemotherapy
  • Ara-C — DRUG
    chemotherapy
  • Dexamethasone — DRUG
    corticosteroide
  • BCNU — DRUG
    chemotherapy
  • Melphalan — DRUG
    chemotherapy
  • Etoposide — DRUG
    chemotherapy
  • G-CSF — DRUG
    growth factor
  • chemotherapy: R-CHOP — PROCEDURE
    immuno-chemotherapy
  • chemotherapy: R-DHAP — PROCEDURE
    immuno-chemotherapy
  • chemotherapy: Dexa-BEAM — PROCEDURE
    chemotherapy
  • stem cell harvest — PROCEDURE
    procedure
  • total body irradiation — PROCEDURE
    radiation
  • high-dose chemotherapy: Cyclophosphamide — PROCEDURE
    chemotherapy
  • high-dose chemotherapy: Ara-C /Melphalan — PROCEDURE
    chemotherapy

Study Details

The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation \[TBI\]/high dose cytarabine \[ARA-C\]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan \[Dexa-BEAM\]/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma.

Key Dates

Start date
Jul 31, 2004
Status verified
Jul 2009
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Active Comparator: 1
    induction: R-CHOP consoldiation : TBI/Cyclo
  • Experimental: 2
    induction: R-CHOP/DHAP consolditaion: TBI/TAM

Primary Outcome Measure

time to treatment failure after start of therapy

Central Contacts