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
18 Years
59 Years
Both
Lymphoma, B-Cell, Lymphoma, Large-Cell, Diffuse
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate after 4 inductive cycles with R-ACVBP14 or R-CHOP14, in DLBCL CD 20 (+) patients, presenting with 2 or 3 adverse prognostic factors of the aa-IPI Test a Pet-driven strategy Complete response rate after the 4 inductive cycles
Outcome Time Frame:
4 inductive cycles with R-ACVBP14 or R-CHOP14
Safety Issue:
Yes
Principal Investigator
Bertrand Coiffier, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2007.462
NCT ID:
NCT00498043
Start Date:
July 2007
Completion Date:
November 2014
Related Keywords:
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Diffuse
- Lymphoma
- PET
- Chemotherapy
- Rituximab
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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