Primary Outcome Measures:
- Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI
Test a Pet-driven strategy
Complete response rate after the 4 inductive cycles
Secondary Outcome Measures:
- Response according to PET after 2 cycles, 4 cycles
Induction toxicities
Response duration
Disease-, progression-, event-free and overall survival after autologous transplant
Biological factors for prognosis
Pharmacokinetic of rituximab
1) Induction Arm A: 4 cycles of R-ACVBP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.
The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).
The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible.
2) Induction arm B: 4 cycles of R-CHOP, 2 weeks interval. After the 3rd cycle, if PET 2+ (fixing), collection of peripheral blood stem cell progenitors will be organized at the time of hematological recovery under support with G-CSF.
The consolidation treatment will depend on results of PET evaluation after cycle 2 (PET2) and cycle 4 (PET4).
Consolidation 1B(in case of PET 2- PET 4 -):
4 additional cycles of R-CHOP, 2-weeks interval
Consolidation 2 B(in case of PET 2+ PET 4 -):
- 2 cycles high-dose Methotrexate with folinic acid rescue
- High dose with Z- BEAM conditioning regimen followed by autologous transplant
- Salvage(in case of PET 4 +):
The patient will be treated with a salvage regimen, after a biopsy of the residual mass whenever possible