Comparison of HD Chemotherapy Followed by Auto-transplant and R-CHOP in High Risk Patients With DLBCL.

Sponsor
Gruppo Italiano Terapie Innovative nei Linfomi
Study ID
NCT00355199
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkin's lymphomas.

Key Dates

Start date
May 31, 2005
Status verified
Aug 2017
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
246 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-HDS
    R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting.
  • Active Comparator: R-CHOP
    Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).

Primary Outcome Measure

Event Free Survival [ Time Frame: 36 months from end of therapy ]

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