Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2024-10-18
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Regional de Alta Especialidad del Bajio
• Collaborator: Universidad de Guanajuato
• Treatments: Brentuximab Vedotin; Nivolumab; Pembrolizumab

Criteria

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