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NCT Number: NCT00561379

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

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).

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Key information

Conditions

Lymphoma, Large-Cell, Diffuse Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

About this study

Diffuse Large B Cell Lymphoma not previously treated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHOP+RITUXIMAB

Drug

CHOP-14- Rituximab x 8 courses

CEEP-RITUXIMAB

Drug

High dose chemotherapy with rituximab including autologous stem cell support.

Primary outcomes

  1. 3 years Event-free survival ( Kaplan Meier method)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2007
Registry last updated
Jun 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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