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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with DLBCL limited stages and without risk factors | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of first line treatment in patients with stage I and II LBCL | Other | 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 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with recent diagnosis of DLBCL in limited stages without risk factors and no previous history of mliagnant disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astrid Pavlovsky, Dr. | Contact | 5491150613683 | astridp@intramed.net | |
| Paula Freigeiro | Contact | 5491140470052 | gatla.ar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amalia Cerutti, Dr. | Grupo Argentino de Tratamiento de la Leucemia Aguda | Principal Investigator |
| Astrid Pavlovsky, Dr. | Grupo Argentino de Tratamiento de la Leucemia Aguda | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de La Plata | Recruiting | La Plata | Buenos Aires | Argentina |
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The data will become available on June 2021, and will remain available until the end of the clinical trial.
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| 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 |
| Compare our results in terms of OS and PFS with those described in patients treated with R-CHOP x6 | 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 |
| Instituto Privado de Hematologia y Hemoterapia | Recruiting | Paraná | Entre Ríos Province | Argentina |
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| IDHEA Clínica Hematológica | Recruiting | Rosario | Santa Fe Province | Argentina |
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| FUNDALEU | Recruiting | CABA | Argentina |
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| Hospital Italiano de Buenos Aires | Recruiting | CABA | Argentina |
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| Clínica Universitaria Reina Fabiola | Recruiting | Córdoba | Argentina |
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| Hospital Privado de Córdoba | Recruiting | Córdoba | Argentina |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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