Lymphoma, Large-Cell, Diffuse
Conditions
Keywords
Diffuse Large B Cell Lymphoma, not previously treated
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
Interventions
DRUGCHOP+RITUXIMAB
CHOP-14- Rituximab x 8 courses
DRUGCEEP-RITUXIMAB
High dose chemotherapy with rituximab including autologous stem cell support.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years Event-free survival ( Kaplan Meier method) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Outcome results
None listed