Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

• Препарат Brentuximab Vedotin 50 MG [Adcetris]
  Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Первичные конечные точки

• Progression free survival [Срок оценки: 24 months]

Вторичные конечные точки (2)

• complete remission [Срок оценки: 24 months]
• overall survival [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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 \> 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.

Критерии исключения

• Voluntary withdrawal from the study.
• Develop grade 3 or 4 toxicity according to the INH scale.
• Loss of follow-up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Hospital Regional Alta Especialidad Bajio — León

Публикации

• Barrera Chavez ID, Viloria Alvarez JC, Zendejas Sanchez V, Rodriguez Esquivel A, Alvarez Salinas A, Amador Medina LF. Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. Indian J Hematol Blood Transfus. 2026 Jan;42(1):93-99. doi: 10.1007/s12288-025-01986-0. Epub 2025 Feb 17. PMID 41522540

Идентификаторы

NCT: NCT05595447 · CI/HRAEB/038/2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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