Spots Global Cancer Trial Database for A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma

Study Description

Brief Summary: This Phase II study randomized R-ACVBP and R-CHOP as induction treatment in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI. The consolidation treatment is allocated according to the response to induction treatment assessed by PET after the 2nd and 4th induction cycles.

Detailed Description: 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). * Consolidation 1A (in case of PET 2- PET 4 -): * High-dose Methotrexate with folinic acid rescue; 2 cycles spaced out 14 days. * Rituximab-Ifosfamide-Etoposide : 4 cycles spaced out 14 days * Cytarabine sub-cutaneous, during 4 days; 2 cycles spaced out 14 days. * Consolidation 2 A (in case of PET 2+ PET4 -): * 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. 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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