Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult
Conditions
Keywords
refractory, relapsed, hodgkin lymphoma
Brief 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?
Detailed description
Patientes with Refractory/relapsed Hodgkin Lymphoma (HL R/R) with multiple failed therapies represent a therapeutic dilemma. The goal of next-line treatment is long-term disease control with manageable adverse reactions. Given the limited therapeutic options for patients with HL R/R, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (OS) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (PFS) of the current standard treatment. Since currently only 50% of the patients with high-risk R/R HL treated with the standard regimen achieve healing. The high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for HL R/R. Based on the above, a treatment strategy is proposed to rescue base with Brentuximab plus PD-1 blockade followed by autotransplantation and consolidation with Brentuximab plus PD-1 blockade in patients with Hodgkin lymphoma High-Risk Relapse/Refractory Compared to Reported OS and PFS Rates in the literature obtained with standard treatment.
Interventions
DRUGBrentuximab Vedotin 50 MG [Adcetris]
Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1
Sponsors
Universidad de Guanajuato
Hospital Regional de Alta Especialidad del Bajio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
Eligibility
Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission | 24 months | complete absence of any disease assessed by PET after established treatment |
| overall survival | 24 months | status at last follow-up alive or dead |
Countries
Mexico
Contacts
Primary ContactLauro Fabián Amador, PhD
Backup ContactJUAN Ojeda Tovar, MD
Outcome results
None listed