Evaluate a Treatment Adapted to the PET Response Compared to a Standard Treatment, for Low Risk DLBCL CD 20+ Patients
Status:
Completed
Trial end date:
2020-05-23
Target enrollment:
Participant gender:
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.