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Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

Primary Purpose

Lymphoma, Large-Cell, Diffuse

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CHOP+RITUXIMAB
CEEP-RITUXIMAB
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large-Cell, Diffuse focused on measuring Diffuse Large B Cell Lymphoma, not previously treated

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 et ≤ 60 and male and female
  • Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 +
  • Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor.
  • Non previously treated
  • HIV négative
  • Signed informed consent

Exclusion Criteria:

  • Age < 18 and/or > 60 ans
  • NHL not DLBCL
  • Lymphoblastic Lymphoma
  • Burkitt's Lymphoma
  • Low grade Lymphoma transformed
  • Primary CNS Lymphomal
  • Post- transplantation Lymphoma
  • CD20 negative
  • Ann Arbor stage I or II without tumor bulk > 7 cm
  • Previous treatment
  • HIV positive
  • Contre-indication to Rituximab use according to SmPC
  • Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma
  • Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma
  • Patient not able to understand the proposed treatments
  • Refusal to sign the informed consent

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

3 years Event-free survival ( Kaplan Meier method)

Secondary Outcome Measures

3 years overall survival
Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
Cost

Full Information

First Posted
November 20, 2007
Last Updated
June 12, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00561379
Brief Title
Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab
Official Title
Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

5. Study Description

Brief Summary
The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).
Detailed Description
Diffuse Large B Cell Lymphoma not previously treated

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large-Cell, Diffuse
Keywords
Diffuse Large B Cell Lymphoma, not previously treated

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHOP+RITUXIMAB
Intervention Description
CHOP-14- Rituximab x 8 courses
Intervention Type
Drug
Intervention Name(s)
CEEP-RITUXIMAB
Intervention Description
High dose chemotherapy with rituximab including autologous stem cell support.
Primary Outcome Measure Information:
Title
3 years Event-free survival ( Kaplan Meier method)
Secondary Outcome Measure Information:
Title
3 years overall survival
Title
Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival
Title
Cost

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 et ≤ 60 and male and female Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 + Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor. Non previously treated HIV négative Signed informed consent Exclusion Criteria: Age < 18 and/or > 60 ans NHL not DLBCL Lymphoblastic Lymphoma Burkitt's Lymphoma Low grade Lymphoma transformed Primary CNS Lymphomal Post- transplantation Lymphoma CD20 negative Ann Arbor stage I or II without tumor bulk > 7 cm Previous treatment HIV positive Contre-indication to Rituximab use according to SmPC Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma Patient not able to understand the proposed treatments Refusal to sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Milpied, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France

12. IPD Sharing Statement

Learn more about this trial

Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

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