NCT00498043

A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma

Randomized Phase II Study of Two Associations of Rituximab and Chemotherapy, With a PET -Driven Strategy, in Patients From 18 to 59 With DLBCL CD20+ Lymphoma and 2 or 3 Adverse Prognostic Factors of the Age-adjusted IPI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphoma, B-Cell
• Lymphoma, Large-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	R-CHOP14 induction regimen	R-CHOP14 induction regimen
DRUG	R-ACVBP14 induction regimen	R-ACVBP14 induction regimen

Timeline

• Start date: 2007-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2007-07-09
• Last updated: 2025-09-03

Locations

1 site across 1 country: France