Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Study Overview
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Brief Summary
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The choice of the best second-line therapy in patients with high LH R/R risk, it is a niche of knowledge not covered at the moment, especially the role of Brentuximab (BV) plus PD-1 blockade and auto-HSCT. What is the progression-free survival and rate of metabolic responses complete in patients with high-risk R/R HL with the treatment strategy: BV+ PD-1 blockade consolidation with Auto-HSCT and maintenance with BV + PD-blockade 1?

Detailed Description
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Patientes with Refractory/relapsed Hodgkin Lymphoma (HL R/R) with multiple failed therapies represent a therapeutic dilemma. The goal of next-line treatment is long-term disease control with manageable adverse reactions. Given the limited therapeutic options for patients with HL R/R, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (OS) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (PFS) of the current standard treatment. Since currently only 50% of the patients with high-risk R/R HL treated with the standard regimen achieve healing. The high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for HL R/R. Based on the above, a treatment strategy is proposed to rescue base with Brentuximab plus PD-1 blockade followed by autotransplantation and consolidation with Brentuximab plus PD-1 blockade in patients with Hodgkin lymphoma High-Risk Relapse/Refractory Compared to Reported OS and PFS Rates in the literature obtained with standard treatment.

Official Title
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Rescue With Brentuximab Plus PD-1 Blockade Followed by Autotransplantation and Consolidation With Brentuximab Plus PD-1 Blockade in Patients With Relapsed/Refractory Hodgkin Lymphoma: Exploratory Single-arm Analysis

Conditions
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Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult

Intervention / Treatment
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* Drug: Brentuximab Vedotin 50 MG [Adcetris]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk. Age ≥ 18 years and ≤ 90 years. Adequate liver function, defined as: Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN Serum alanine aminotransferase (ALT) ≤ 3.0 x ULN Adequate renal functions, defined as: • Serum creatinine ≤ 1.5x ULN or glomerular filtration rate &gt; 50ml/min. ECOG performance status ≤ 3 Women of reproductive potential should have a serum pregnancy test or negative urine. Prior signature of the informed consent. Exclusion Criteria: Voluntary withdrawal from the study. Develop grade 3 or 4 toxicity according to the INH scale. Loss of follow-up

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1<br>Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles | Drug: Brentuximab Vedotin 50 MG [Adcetris]<br>* Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1<br>* Other names: Pembrolizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | complete absence of any disease assessed by PET after established treatment | 24 months | 
| overall survival | status at last follow-up alive or dead | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory, relapsed, hodgkin lymphoma