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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00965289
• Collaborator: French Innovative Leukemia Organisation (Other), Hoffmann-La Roche (Industry)
• Enrollment: 42
• Location: 1
• Arm: 1
• Duration (Months): 86
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-Cell Lymphoma	Drug: Rituximab	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: May 1, 2003
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Rituximab; Rituximab infusion on day 1 dose: 375mg/m²; Other Names: Mabthera®

Outcome Measures

Primary Outcome Measures

1. CR rate after 3 high dose chemotherapy courses [safety/efficacy of chemotherapy treatment]

Secondary Outcome Measures

1. CR and PR rate at the end of the study treatment [safety/efficacy of treatment30 days after the end of post ASCT aplasia]

2. PFS,EFS and OS [safety/efficacy of study treatment]

3. Tolerance of Rituximab combined with chemotherapy [safety/efficacy of immunotherapy combined with chemotherapy treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Nantes		France	44000

Sponsors and Collaborators

• Nantes University Hospital
• French Innovative Leukemia Organisation
• Hoffmann-La Roche

Investigators

• Principal Investigator: Noel MILPIED, PD MS, CHU NANTES/GOELAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00965289
• Other Study ID Numbers: GOELAMS 074
• First Posted: Aug 25, 2009
• Last Update Posted: Aug 26, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: Aggressive large B-cell lymphoma (DLBCL); Intensive chemotherapy; Rituximab; ASCT
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Aggression; Rituximab

Study Results

No Results Posted as of Aug 26, 2009