Lymphoma, Large-Cell, Diffuse
Conditions
Keywords
lymphoma, autologous stem cell transplant, chemotherapy, BCL2
Brief summary
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
Interventions
DRUGdoxorubicin
DRUGcyclophosphamide
PROCEDUREAutologous stem cell transplantation
Sponsors
Fondation ARC
Lymphoma Study Association
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling) * Aged 18 to 60 years * Non previously treated * With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level * Negative HIV, HBV and HCV serologies (except vaccination) * With a minimum life expectancy of 3 months * Having previously signed a written informed consent
Exclusion criteria
* Any history of treated or non-treated indolent lymphoma. * T-cell lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Any Contra-indication to any drug contained in the chemotherapy regimens. * Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Serious active disease (according to the investigator's decision). * Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Childbearing woman. * Patients previously treated with an organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate at the end of treatment. | — |
| Disease-free survival for complete responders. | — |
| Overall survival. | — |
Countries
Belgium, France
Outcome results
None listed