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

Primary Purpose

B-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Lymphoma focused on measuring Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HDT combined with rituximab before ASCT

Arm Description

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.

Outcomes

Primary Outcome Measures

CR rate after 3 high dose chemotherapy courses

Secondary Outcome Measures

CR and PR rate at the end of the study treatment
PFS,EFS and OS
Tolerance of Rituximab combined with chemotherapy

Full Information

First Posted
August 24, 2009
Last Updated
August 25, 2009
Sponsor
Nantes University Hospital
Collaborators
French Innovative Leukemia Organisation, Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00965289
Brief Title
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
Official Title
Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital
Collaborators
French Innovative Leukemia Organisation, Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Lymphoma
Keywords
Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HDT combined with rituximab before ASCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera®
Intervention Description
Rituximab infusion on day 1 dose: 375mg/m²
Primary Outcome Measure Information:
Title
CR rate after 3 high dose chemotherapy courses
Time Frame
safety/efficacy of chemotherapy treatment
Secondary Outcome Measure Information:
Title
CR and PR rate at the end of the study treatment
Time Frame
safety/efficacy of treatment30 days after the end of post ASCT aplasia
Title
PFS,EFS and OS
Time Frame
safety/efficacy of study treatment
Title
Tolerance of Rituximab combined with chemotherapy
Time Frame
safety/efficacy of immunotherapy combined with chemotherapy treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel MILPIED, PD MS
Organizational Affiliation
CHU NANTES/GOELAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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

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