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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate (CR + CRu)
4 cycles of ACVBP
Olivier Fitoussi, MD
Lymphoma Study Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)