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

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ClinicalTrials.gov Identifier: NCT00561379
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : June 13, 2013
Sponsor:
Information provided by:

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).

Condition or disease Intervention/treatment
Lymphoma, Large-Cell, Diffuse Drug: CHOP+RITUXIMAB Drug: CEEP-RITUXIMAB

Detailed Description:
Diffuse Large B Cell Lymphoma not previously treated

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2005
Primary Completion Date : May 2013
Study Completion Date : May 2013


Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Drug: CHOP+RITUXIMAB
CHOP-14- Rituximab x 8 courses
Active Comparator: 2 Drug: CEEP-RITUXIMAB
High dose chemotherapy with rituximab including autologous stem cell support.


Outcome Measures

Primary Outcome Measures :
  1. 3 years Event-free survival ( Kaplan Meier method)

Secondary Outcome Measures :
  1. 3 years overall survival
  2. 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
  3. Cost

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561379


Locations
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Noel Milpied, MD CHU Bordeaux
More Information

ClinicalTrials.gov Identifier: NCT00561379     History of Changes
Other Study ID Numbers: BRD 04/4-O
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013

Keywords provided by Nantes University Hospital:
Diffuse Large B Cell Lymphoma
not previously treated

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents