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Clinical Trials in Mexico / NCT05595447
Recruiting Phase 2/3

Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

NCT05595447 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital Regional de Alta Especialidad del Bajio
Phase
Phase 2/3
Started
2022-10-18
Last updated
2025-03-12

Condition(s) studied

Hodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Hodgkin's Disease, Adult

Investigational drug(s) / intervention(s)

Brentuximab Vedotin 50 MG [Adcetris] →

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

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

1?

Eligibility

Sex
ALL
Min age
15 Years
Max age
90 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Progression free survival — 24 months
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

Trial sites (1)

FacilityCityRegionStatus
Hospital Regional Alta Especialidad Bajio León Guanajuato Recruiting

More Hospital Regional de Alta Especialidad del Bajio trials in Mexico

Raman Spectroscopy Compared to Flow Cytometry Recruiting
Cohort of Mexican Children With Diabetes Mellitus (CMC-DM) Recruiting

Other trials for the same condition

Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595447 on ClinicalTrials.gov ↗ ← All trials in Mexico