Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)
18 Years
59 Years
Both
Diffuse Large Cell Lymphoma
Trial Information
Study of ACVBP Plus Rituximab in Previously Untreated Patients Aged From 18 to 59 Years With High Risk Diffuse Large B-cell Lymphoma (Age-adjusted IPI = 2-3)
This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH
93-3 and LNH 98-3B studies.
To date, the ACVBP regimen is considered as the reference induction treatment of the GELA in
patients with 2-3 adverse prognostic factors. Indeed neither NCVBP regimen (LNH87-2) nor
ECVBP (LNH93-3) led to increase the complete remission rate. More recently, the addition of
etoposide to doxorubicin and cyclophosphamide (LNH98-3B) did not enhanced the complete
remission rate with more toxicity. In patients < 60 years with 2-3 adverse prognostic
factors the complete remission rate remained less than 65% in all these studies.
Consequently, increasing the quality of response remains a major goal in this group of young
patients with adverse prognostic factors.
It has been shown that the addition of rituximab to CHOP regimen significantly improved the
CR rate in elderly patients with previously untreated large B-cell lymphoma when compared
with CHOP alone without additional toxicities. Moreover, event-free survival and overall
survival were found to be longer in the R-CHOP group. The present trial will evaluate the
response rate obtained after four cycles of ACVBP combined to rituximab (R-ACVBP) before
high dose therapy consolidative treatment in this group of higher risk patients.
The LNH87-2 study has shown that intensive consolidation treatment with autologous stem cell
support was beneficial to high risk patients in good response after a full induction phase.
The long-term results of this randomised study prompted us to consider high dose therapy as
the best consolidative option for these patients.
Inclusion Criteria:
Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO
classification).
Age from 18 to 59 years, eligible for transplant. Patient not previously treated. Age
adjusted IPI = 2 or 3 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV
serologies < 4 weeks (except after vaccination). Having signed a written informed consent.
Exclusion Criteria:
Any history of treated or non-treated indolent lymphoma. However, patients not previously
diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in
bone marrow or lymph node may be included.
Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug
contained in the chemotherapy regimens. Poor renal function (creatinin level >150 mmol/l),
poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal
level) unless these abnormalities are related to the lymphoma.
Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/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.
Any serious active disease (according to the investigator's decision). Treatment with any
investigational drug within 30 days before planned first cycle of chemotherapy and during
the study.
Pregnant or lactating women Adult patient under tutelage.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete remission rate (CR + CRu)
Outcome Time Frame:
4 cycles of ACVBP
Safety Issue:
No
Principal Investigator
Olivier Fitoussi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Lymphoma Study Association
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
LNH03-3B
NCT ID:
NCT00144807
Start Date:
December 2003
Completion Date:
September 2008
Related Keywords:
- Diffuse Large Cell Lymphoma
- lymphoma, diffuse large B-cell
- rituximab
- chemotherapy
- autologous stem cell transplant
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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