Hodgkin Lymphoma Clinical Trial
Official title:
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
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?
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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Regional Alta Especialidad Bajio | Leon | Guanajuato |
Lead Sponsor | Collaborator |
---|---|
Hospital Regional de Alta Especialidad del Bajio | Universidad de Guanajuato |
Mexico,
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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