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

Civil Hospices of Lyon

Status and phase

Completed

Phase 2

Conditions

Lymphoma, Large-Cell, Diffuse

Lymphoma, B-Cell

Treatments

Drug: R-ACVBP14 induction regimen

Drug: R-CHOP14 induction regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT00498043

2007.462

Details and patient eligibility

About

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.

Full 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

Enrollment

222 patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
Age from18 to 59 years, eligible for transplant.
Patient not previously treated.
Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion.
Index prognostic factors (IPI) 2 or 3.
With a minimum life expectancy of 3 months.
Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination).
Having previously signed a written informed consent.

Exclusion criteria

Any other histological type of lymphoma.
Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
Central nervous system or meningeal involvement by lymphoma.
Contra-indication to any drug contained in the chemotherapy regimens.
Poor renal function (creatinin level >150 mmol/l), poor hepatic function (total bilirubin level >30 mmol/l, transaminases >2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.
Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ)cervical carcinoma.
Any serious active disease (according to the investigator's decision).
Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy.
Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
Adult patient under tutelage.
Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning