High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

Sponsor
Nantes University Hospital
Study ID
NCT00965289
Phase
PHASE2
Status
Completed

Conditions

  • B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab infusion on day 1 dose: 375mg/m²

Study Details

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Key Dates

Start date
Apr 30, 2002
Status verified
Aug 2009
Primary completion
May 31, 2003
Completion
Jun 30, 2009

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HDT combined with rituximab before ASCT
    The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Primary Outcome Measure

CR rate after 3 high dose chemotherapy courses [ Time Frame: safety/efficacy of chemotherapy treatment ]

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