Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Phase 3RecruitingNCT05595447

Hospital Regional de Alta Especialidad del Bajio20 enrolled

Overview

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?

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 15 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk. 2. Age ≥ 18 years and ≤ 90 years. 3. 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 4. Adequate renal functions, defined as: • Serum creatinine ≤ 1.5x ULN or glomerular filtration rate \> 50ml/min. 5. ECOG performance status ≤ 3 6. Women of reproductive potential should have a serum pregnancy test or negative urine. 7. Prior signature of the informed consent. Exclusion Criteria: 1. Voluntary withdrawal from the study. 2. Develop grade 3 or 4 toxicity according to the INH scale. 3. Loss of follow-up

Outcomes

Primary Outcomes

Progression free survival

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

Time frame: 24 months

Secondary Outcomes

complete remission

complete absence of any disease assessed by PET after established treatment

Time frame: 24 months

overall survival

status at last follow-up alive or dead

Time frame: 24 months

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts