NCT05595447

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Regional de Alta Especialidad del Bajio · Academic / Other
• Sex: All
• Age: 15 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin 50 MG [Adcetris]	Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Timeline

• Start date: 2022-10-18
• Primary completion: 2025-10-18
• Completion: 2025-10-18
• First posted: 2022-10-27
• Last updated: 2025-03-12

Locations

1 site across 1 country: Mexico