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

Grupo Argentino de Tratamiento de la Leucemia Aguda

Status: Enrolling

Conditions: Lymphoma, Non-Hodgkin's, Adult

Treatments: Other: Evaluation of first line treatment in patients with stage I and II LBCL

Study type: Observational

Funder types: Other

Identifiers

NCT05078840

GATLA 10-LNHDCG-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 17 years old with no upper age limit.
• Histological diagnosis of DLBCL Stages I or II
• Patients who have signed informed consent.

Exclusion criteria

• Patients with elevated LDH (lactate dehydrogenase)
• ECOG (Eastern Cooperative Oncology Group) > 2
• Stage III or IV
• Bulky mass (> 7.5 cm)
• Central nervous system involvement
• Testicular lymphoma
• Breast involvement
• Eyeball involvement
• Primary mediastinal lymphoma
• Cutaneous primary lymphoma
• Diffuse large B-cell lymphoma of the leg
• HIV positive patients
• Platelet count <100,000 / mcl and total leukocyte count <3,000 / mcl
• Marked impairment of ventricular function (FEy <50%)
• Moderate / severe renal impairment defined by Cl. Cr. <50 ml / min
• Severe liver disease: prothrombin rate <50% and / or bile level. total> 2.5 times normal value
• Pregnant and breastfeeding
• Previous or concomitant diagnosis of indolent lymphoma
• Patients who have previously received chemotherapy and / or radiotherapy

Trial design

75 participants in 1 patient group

Patients with DLBCL limited stages and without risk factors

Description:

Patients with DLBCL in limited stages and without risk factors that will receive standard chemoimmunotherapy and their treatment will be adapted according to PET response after 3 cycles.

Treatment:

Other: Evaluation of first line treatment in patients with stage I and II LBCL