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

B-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965289
• Other study ID #: GOELAMS 074
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2009
• Last updated: August 25, 2009
• Start date: April 2002
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2009
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS, Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR rate after 3 high dose chemotherapy courses		safety/efficacy of chemotherapy treatment	Yes
Secondary	CR and PR rate at the end of the study treatment		safety/efficacy of treatment30 days after the end of post ASCT aplasia	Yes
Secondary	PFS,EFS and OS		safety/efficacy of study treatment	Yes
Secondary	Tolerance of Rituximab combined with chemotherapy		safety/efficacy of immunotherapy combined with chemotherapy treatment	Yes