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

NCT00965289 | Completed Phase 2 DMC

• 1 other identifier: GOELAMS 074
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

B-Cell Lymphoma

Keywords

Aggressive large B-cell lymphoma (DLBCL); Intensive chemotherapy; Rituximab; ASCT

Outcome Measures

Primary Outcomes (1)

• CR rate after 3 high dose chemotherapy courses

  safety/efficacy of chemotherapy treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

HDT combined with rituximab before ASCT

EXPERIMENTAL

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

Interventions

Rituximab DRUG

Rituximab infusion on day 1 dose: 375mg/m²

Also known as: Mabthera®

HDT combined with rituximab before ASCT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital

Nantes, 44000, France

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Noel MILPIED, PD MS

  CHU NANTES/GOELAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: April 1, 2002
• Primary Completion: May 1, 2003
• Study Completion: June 1, 2009
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

FR (1)