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

Phase 2

Completed

• Conditions: B-Cell Lymphoma
• Interventions: Drug: Rituximab

• Registration Number: NCT00965289
• Lead Sponsor: Nantes University Hospital

Brief 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.

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2003-05
• Study Completion: 2009-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age 18 to 60 y.o
• Aggressive Large B-Cell Lymphoma (CD20+)
• Ann Arbor stage III, IV
• IH or high adjusted IPI
• signed inform consent

Exclusion Criteria

• Age < 18 ou > 60 y.o
• other type of lymphoma
• serology VIH +
• other neoplasms apart from basal cell carcinoma or situ carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HDT combined with rituximab before ASCT	Rituximab	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 Measures

Name	Time	Method
CR rate after 3 high dose chemotherapy courses	safety/efficacy of chemotherapy treatment

Secondary Outcome Measures

Name	Time	Method
CR and PR rate at the end of the study treatment	safety/efficacy of treatment30 days after the end of post ASCT aplasia
PFS,EFS and OS	safety/efficacy of study treatment
Tolerance of Rituximab combined with chemotherapy	safety/efficacy of immunotherapy combined with chemotherapy treatment

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France