Evaluate a Treatment Adapted to the PET Response Compared to a Standard Treatment, for Low Risk DLBCL CD 20+ Patients

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.

Timeline

Start

2010-12

Primary completion

2020-05-23

Completion

2020-05-23

Outcome

Met primary endpoint

paper The noninferiority of the experimental PET-adapted arm was demonstrated (hazard ratio 0.72, 95% CI 0.47-1.12, P value < 0.0001). PMID 41260259 ↗

Publications

• Michot JM, Bologna S, Bastie JN, Borght TV, Briere J, Ribrag V, Bommier C, Peyrade F, Lebras L, Damaj G, Coso D, Sibon D, Bonnet C, Morschhauser F, Ghesquieres H, Fruchart C, Soussain C, Becker S, Olivier P, Julian A, Molina T, Haioun C, Tilly H. Early positron emission tomography response-adapted treatment in low-risk diffuse large B-cell lymphoma: an open-label, multicenter, randomized, noninferiority phase III trial. Ann Oncol. 2026 Mar;37(3):403-413. doi: 10.1016/j.annonc.2025.11.006. Epub 2025 Nov 17.

Drugs

Indications