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GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

NCT01659099 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2018-03-07

No results posted yet for this study

Summary

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.

Conditions

  • Diffuse Large B Cell Lymphoma CD20 Positive

Interventions

DRUG

GA101

in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)

DRUG

Rituximab

in R-ACBVP or in R-CHOP 375 mg/m² on D1

DRUG

Doxorubicin

in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1

DRUG

Cyclophosphamide

in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1

DRUG

Prednisone

in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5

DRUG

Bleomycin

in ACBVP 10 mg from D1 to D5

DRUG

Vindesin

in ACBVP 2 mg/m² from D1 to D5

DRUG

Vincristine

in CHOP 1,4 mg/m² on D1

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Olivier Casasnovas, MD · Lymphoma Study Association

  • Steven Le Gouill, MD · Lymphoma Study Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-08-31
Completion
2017-12-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659099 on ClinicalTrials.gov