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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


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

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