Evaluate a Treatment Adapted to the PET Response Compared to a Standard Treatment, for Low Risk DLBCL CD 20+ Patients
Condition: DLBCL
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, the investigators purpose is to evaluate the adaptation of treatment with
      early response based on PET scan results after 2 cycles of chemotherapy, for patient aged
      from 18 to 80 years, with low IPI DLBCL.

      This is an open randomized study.

      The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non
      inferiority of the experimental arm in comparison to standard arm:

      In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account
      of PET scan results after 2 cycles.

      In experimental arm, early good responder patients (defined as having a negative PET scan
      after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

      In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam
      is needed to confirm the failure and an intensive chemotherapy is then recommended.

      All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan
      will be reviewed by a group of expert according to Deauville criteria defined by Meignan et
      al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for
      all patients. The final evaluation of response will be made according to 2007 Cheson's
      criteria.
    

Detailed description: 
      Localized stages DLBCL with low IPI (aaIPI = 0) have a very good prognostic after a standard
      immuno-chemotherapy with 6 cycles of R-CHOP 21. Five years PFS is estimated over 75%,
      whatever the age of the patient.

      PET scan is actually considered as "the gold standard" for the initial staging and the
      evaluation of response after treatment. With this new technique, the response criteria have
      been redefined by Cheson and al. in 2007. Moreover, several recent studies showed that early
      evaluation of response with PET scan after only 2 cycles of chemotherapy was accurate to
      define two groups of patients:

      "Early-good-responders", when PET scan is negative "Early-poor-responders", when PET scan
      remains positive Prognostic for the first group is very good, and for the second poorer. At
      the present time, the interest of the modification and/or the intensification of the
      treatment for the early-poor-responder patients is not demonstrated by any publication. New
      studies are ongoing for patients with advanced stages of DLBC NHL (GELA trial LNH 07-3B) or
      Hodgkin's lymphoma (GELA and EORTC trial H10); the aim is to evaluate a new strategy of
      treatment adapted to early response criteria.

      No trial has already been made for low IPI DLBCL. In this study, the investigators purpose is
      to evaluate the adaptation of treatment with early response based on PET scan results after 2
      cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

      This is an open randomized study.

      The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non
      inferiority of the experimental arm in comparison to standard arm:

      In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account
      of PET scan results after 2 cycles.

      In experimental arm, early good responder patients (defined as having a negative PET scan
      after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

      In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam
      is needed to confirm the failure and an intensive chemotherapy is then recommended.

      All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan
      will be reviewed by a group of expert according to Deauville criteria defined by Meignan et
      al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for
      all patients. The final evaluation of response will be made according to 2007 Cheson's
      criteria.
    

Intervention name(s): RCHOP21
Intervention type(s): Drug
Intervention description(s): Prednisone-60 mg/m2: D1 D2 D3 D4 D5;Rituximab-375 mg/m2 : D1; Doxorubicin-50 mg/m2 D1;Cyclophosphamide-750 mg/m2:D1 Vincristine-1.4 mg/m2 :D1; G-CSF SC -5 microg/kg/day: D6 to D13
Other intervention name(s): Rituximab-CHOP21
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment