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

GA101

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

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

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

Vindesin

Olivier Casasnovas, MD

Steven Le Gouill, MD

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.

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI

EFS is defined as PET positivity according to ΔSUVmax criteria after 2 or 4 induction cycles as defined by RAC (based on central PET review), progression or relapse according to Cheson 2007, modification of planned treatment out of progression or death of any cause.

Response will be assessed after 4 cycles and again at the end of treatment, based on RAC assessment for PET 4 and investigator assessment for EoT PET. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007). Overall (CR//PR) response rates and Best Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.

Response will be assessed after 4 cycles and at the end of treatment, based on investigator assessment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999). Overall (CR/CRu/PR) response rates and Best Overall Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.

Duration of response is defined as the period from the time of attainment a CR or PR to the date of progression, relapse or death from any cause. Duration or response would be assessed as survival in the whole population, in the two inductive arms (R-Chemo14 vs GA101-Chemo14) For patients achieving a response but who have not progressed or relapsed or died at the time of analysis, DOR will be censored on the date of last disease assessment

Progression-Free Survival is defined as the period from the date of randomization to the date of first documented disease progression, relapse, or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of last disease assessment. If no tumor assessments were performed after the baseline visit, PFS will be censored at the time of randomization

Overall survival is defined as the period from the date of randomization to the date of death from any cause. Alive patients at the time of the analysis will be censored at their last contact date

Analysis on blood samples and tumor tissue biopsy will be driven, in order to explore prognosis factors of the patients and their tumors that influence treatment response based on PET assessment and prognosis

Duration of response, PFS and OS will be performed according to treatment arms (R-Chemo14 vs GA101-Chemo14) on different analysis populations. The subpopulations are based on the outcome during the induction phase and a statistical bias could be introduced as subpopulations have not been defined at baseline.

* Population with a Δ SUVmaxPET0-2≤66% (slow and intermediate responders),
* Population with a Δ SUVmaxPET0-2\>66% (fast responders),
* Patients submitted to autologous stem cell transplant (PFS and OS only)

Number of stem cell collected after GA101 administration Number of required collects to achieve 3Mcells/kg.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma	NCT01659099	Diffuse Large B...	GA101 Rituximab Doxorubicin Cyclophosphamid... Prednisone Bleomycin Vindesin Vincristine	18 Years - 60 Years	The Lymphoma Academic Research Organisation
GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma	NCT01659099	Diffuse Large B...	GA101 Rituximab Doxorubicin Cyclophosphamid... Prednisone Bleomycin Vindesin Vincristine	18 Years - 60 Years	The Lymphoma Academic Research Organisation

Spots Global Cancer Trial Database for diffuse large b cell lymphoma cd20 positive