A Study of Two Associations of Rituximab and Chemotherapy, With a PET-driven Strategy, in Lymphoma — LNH2007-3B  

Lymphoma, B-Cell Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT00498043
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Completion date: October 2013