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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    75
  • sponsor
    Grupo Argentino de Tratamiento de la Leucemia Aguda
Updated on 20 October 2021

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.

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.

Details
Condition Lymphoma, Non-Hodgkin's, Adult
Treatment Evaluation of first line treatment in patients with stage I and II LBCL
Clinical Study IdentifierNCT05078840
SponsorGrupo Argentino de Tratamiento de la Leucemia Aguda
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

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)
Extranodal involvement (patients with testicular, central nervous system and primary mediastinal non-Hodgkin's lymphoma are excluded)
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
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