Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
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
Hospital Regional de Alta Especialidad del Bajio
20 participants
Oct 18, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria3
- Voluntary withdrawal from the study.
- Develop grade 3 or 4 toxicity according to the INH scale.
- Loss of follow-up
Interventions
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05595447