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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00561379
First received: November 20, 2007
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Lymphoma, Large-Cell, Diffuse
 Drug: CHOP+RITUXIMAB
Drug: CEEP-RITUXIMAB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

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

Estimated Enrollment: 350
Study Start Date: April 2005
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

Diffuse Large B Cell Lymphoma not previously treated

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561379

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

No publications provided

ClinicalTrials.gov Identifier: NCT00561379     History of Changes
Other Study ID Numbers: BRD 04/4-O
Study First Received: November 20, 2007
Last Updated: November 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013