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

First listed
Aug 25, 2009
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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