Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

Last updated: March 10, 2025
Sponsor: Hospital Regional de Alta Especialidad del Bajio
Overall Status: Active - Recruiting

Phase

2/3

Condition

Lymphoma

Hematologic Cancer

Platelet Disorders

Treatment

Brentuximab Vedotin 50 MG [Adcetris]

Clinical Study ID

NCT05595447
CI/HRAEB/038/2022
  • Ages 15-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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Eligibility Criteria

Inclusion

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

  1. Adequate renal functions, defined as:

• Serum creatinine ≤ 1.5x ULN or glomerular filtration rate > 50ml/min.

  1. ECOG performance status ≤ 3

  2. Women of reproductive potential should have a serum pregnancy test or negativeurine.

  3. Prior signature of the informed consent.

Exclusion

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Brentuximab Vedotin 50 MG [Adcetris]
Phase: 2/3
Study Start date:
October 18, 2022
Estimated Completion Date:
October 18, 2025

Study 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.

Connect with a study center

  • Hospital Regional Alta Especialidad Bajio

    Leon, Guanajuato 37660
    Mexico

    Active - Recruiting

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