PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors

Lymphoma, Non-Hodgkin's, Adult Clinical Trial

Official title: Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)

Status Recruiting

Clinical Trial Summary

Prospective, multicenter, phase IV study, of real-life evidence destined to evaluate the feasibility and efficacy of performing a treatment adapted to PET-CT in patients with stage I and II DLBCL, without poor prognostic factors.

Clinical Trial Description

Patients older than 17 years of age, with no upper age limit with a de novo histological diagnosis of DLBCL, in stages I and II and without risk factors, will be included. All patients will have a baseline PET-CT and will undergo 3 cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). A PET-CT will be performed on day 15-18 of the third cycle that will be centrally reviewed. Those patients with negative PET-CT (Deauville 1, 2 and 3) will receive an additional cycle of R-CHOP and will finish treatment. Patients who have PET-CT with a Deauville 4 score will complete a fourth cycle and then receive radiation therapy to the compromised site. Those patients with a Deauville score of 5 should receive rescue therapy, so they will be outside the protocol. A standardized follow-up of the patients included with tomographic controls will be carried out, evaluating OS (overall survival) and PFS (progression-free survival) at 3 years as the main objectives. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's, Adult

• NCT number: NCT05078840
• Study type: Observational [Patient Registry]
• Source: Grupo Argentino de Tratamiento de la Leucemia Aguda
• Contact: Astrid Pavlovsky, Dr.
• Phone: 5491150613683
• Email: astridp@intramed.net
• Status: Recruiting
• Start date: June 1, 2021
• Completion date: June 1, 2025