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NCT Number: NCT05595447

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

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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Key information

Age range

15 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Regional Alta Especialidad Bajio

León, Guanajuato, 37660, Mexico

Location status: Recruiting

Location contact

Lauro F Amador, Researcher

CONTACT

[email protected]

477 2672000 ext. 1512

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 > 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

Treatment and study plan

Brentuximab Vedotin 50 MG [Adcetris]

Drug

Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Other names: Nivolumab, Pembrolizumab

Primary outcomes

  1. Progression free survival

    Time frame: 24 months

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

Secondary outcomes

  1. complete remission

    Time frame: 24 months

    complete absence of any disease assessed by PET after established treatment

  2. overall survival

    Time frame: 24 months

    status at last follow-up alive or dead

Study contacts

Contact information is provided by the study sponsor or research team.

JUAN Ojeda Tovar, MD

CONTACT

[email protected]

(477) 267 2000

Lauro Fabián Amador, PhD

CONTACT

[email protected]

4772697907

Sponsors and collaborators

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio

Other

Collaborators

  • Universidad de Guanajuato

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2022
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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