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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05595447
Other study ID # CI/HRAEB/038/2022
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 18, 2022
Est. completion date October 18, 2025

Study information

Verified date February 2024
Source Hospital Regional de Alta Especialidad del Bajio
Contact Lauro Fabián Amador, PhD
Phone 4772697907
Email lafab2013@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 18, 2025
Est. primary completion date October 18, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brentuximab Vedotin 50 MG [Adcetris]
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1

Locations

Country Name City State
Mexico Hospital Regional Alta Especialidad Bajio Leon Guanajuato

Sponsors (2)

Lead Sponsor Collaborator
Hospital Regional de Alta Especialidad del Bajio Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. 24 months
Secondary complete remission complete absence of any disease assessed by PET after established treatment 24 months
Secondary overall survival status at last follow-up alive or dead 24 months
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