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Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

RECRUITINGPhase 2/3Sponsored by Hospital Regional de Alta Especialidad del Bajio
Actively Recruiting
PhasePhase 2/3
SponsorHospital Regional de Alta Especialidad del Bajio
Started2022-10-18
Est. completion2025-10-18
Eligibility
Age15 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05595447

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

Age: 15 Years – 90 YearsHealthy 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

Conditions4

CancerHodgkin LymphomaRefractory Hodgkin LymphomaRelapsed Hodgkin's Disease, Adult

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