NCT00965289

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

Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Conditions

• B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab infusion on day 1 dose: 375mg/m²

Timeline

• Start date: 2002-04-01
• Primary completion: 2003-05-01
• Completion: 2009-06-01
• First posted: 2009-08-25
• Last updated: 2009-08-26

Locations

1 site across 1 country: France