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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Patients With Diffuse Large B-cell Non-Hodgkins Lymphoma in Stages I and II Without Risk Factors, Adapted to the Response Evaluated With PET CT (Positron Emission Computed Tomography)

Conditions
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Lymphoma, Non-Hodgkin's, Adult

Intervention / Treatment
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* Other: Evaluation of first line treatment in patients with stage I and II LBCL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with DLBCL limited stages and without risk factors<br>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. | Other: Evaluation of first line treatment in patients with stage I and II LBCL<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, DLBCL