GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

Conditions

• Diffuse Large B Cell Lymphoma CD20 Positive

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• GA101 — DRUG
  in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
• Rituximab — DRUG
  in R-ACBVP or in R-CHOP 375 mg/m² on D1
• Doxorubicin — DRUG
  in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
• Cyclophosphamide — DRUG
  in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
• Prednisone — DRUG
  in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
• Bleomycin — DRUG
  in ACBVP 10 mg from D1 to D5
• Vindesin — DRUG
  in ACBVP 2 mg/m² from D1 to D5
• Vincristine — DRUG
  in CHOP 1,4 mg/m² on D1

Study Details

This study is designed to investigate: * the interest of a new monoclonal antibody (GA101)versus rituximab * the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

Key Dates

Start date

Sep 30, 2012

Status verified

Mar 2018

Primary completion

Aug 31, 2016

Completion

Dec 31, 2017

Study Design

Enrollment

671 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GA101
  GA101 - Chemotherapy (ACVBP or CHOP)
• Active Comparator: Rituximab
  Rituximab - Chemotherapy (ACVBP or CHOP)

Primary Outcome Measure

2-year Event Free Survival [ Time Frame: Up to 2 years ]