PET Adapted Treatment of Patients With Limited Stage DLBCL and no Risk Factors
- Conditions
- Lymphoma, Non-Hodgkin's, Adult
- Interventions
- Other: Evaluation of first line treatment in patients with stage I and II LBCL
- Registration Number
- NCT05078840
- Lead Sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- Patients > 17 years old with no upper age limit.
- Histological diagnosis of DLBCL Stages I or II
- Patients who have signed informed consent.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with DLBCL limited stages and without risk factors Evaluation of first line treatment in patients with stage I and II LBCL 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.
- Primary Outcome Measures
Name Time Method Evaluate PFS in patients with stage I and II LBCL (large B cell lymphoma), without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP. 36 months Evaluate OS in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP 36 months
- Secondary Outcome Measures
Name Time Method Evaluate the prognostic value of baseline TLG (total lesion glycolysis) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP 36 months Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx4+ 2 Rituximab or R-CHOPx 4 + ISRT (involved site radiation therapy) + Zevalin 36 months Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 cycles of R-CHOP. 36 months Evaluate PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy. 36 months Evaluate the prognostic value of baseline MTV (metabolic tumor volume) in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP 36 months Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi with R-CHOPx 4 + RTCC + Zevalin 36 months Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6 36 months Evaluate the prognostic value of Δ SUV (standardized uptake value) max in interim PET in patients with DLBCL under treatment adapted to response after 3 cycles of R-CHOP 36 months Compare our results in terms of OS and PFS with those described in patients with treatments adapted to the result of PETi (interim PET) with R-CHOP x 4 (4 cycles of CHOP) 36 months
Trial Locations
- Locations (7)
Hospital Italiano de La Plata
🇦🇷La Plata, Provincia De Buenos Aires, Argentina
FUNDALEU
🇦🇷Caba, Argentina
IDHEA Clínica Hematológica
🇦🇷Rosario, Santa Fe, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Caba, Argentina
Clínica Universitaria Reina Fabiola
🇦🇷Córdoba, Argentina
Hospital Privado de Córdoba
🇦🇷Córdoba, Argentina
Instituto Privado de Hematologia y Hemoterapia
🇦🇷Paraná, Entre Ríos, Argentina