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 (LNH2007-3B)

NCT00498043 Phase 2 COMPLETED

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.

Details

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 2
Status	COMPLETED
Enrolment	222
Start date	2007-07
Completion	2013-10

Conditions

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

Interventions

• R-CHOP14 induction regimen
• R-ACVBP14 induction regimen

Primary outcomes

• 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 — 4 inductive cycles with R-ACVBP14 or R-CHOP14

Countries

France