NCT05078840

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

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Grupo Argentino de Tratamiento de la Leucemia Aguda · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Lymphoma, Non-Hodgkin's, Adult

Interventions

Type	Name	Description
OTHER	Evaluation of first line treatment in patients with stage I and II LBCL	Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2021-10-15
• Last updated: 2024-01-09

Locations

7 sites across 1 country: Argentina