Lymphoma, Non-Hodgkin's, Adult
Conditions
Keywords
PET, DLBCL
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.
Interventions
OTHEREvaluation 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
Sponsors
Grupo Argentino de Tratamiento de la Leucemia Aguda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Evaluate PFS in patients with negative PET after 3rd cycle who shortened treatment to only 4 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 |
| 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 |
| 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 PFS in patients with positive PET after 3rd cycle who continue treatment with R-CHOP x 1 and Radiotherapy. | 36 months |
Countries
Argentina
Contacts
Primary ContactAstrid Pavlovsky, Dr.
Backup ContactPaula Freigeiro
Outcome results
None listed