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| Name | Class |
|---|---|
| Universidad de Guanajuato | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1 | Experimental | Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brentuximab Vedotin 50 MG [Adcetris] | Drug | Brentuximab plus blocked PD-1 plus ASCT plus maintenance Brentuximab plus blocked PD-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission | complete absence of any disease assessed by PET after established treatment | 24 months |
| overall survival | status at last follow-up alive or dead |
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Inclusion Criteria:
Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.
Age ≥ 18 years and ≤ 90 years.
Adequate liver function, defined as:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauro Fabián Amador, PhD | Contact | 4772697907 | lafab2013@gmail.com | |
| JUAN Ojeda Tovar, MD | Contact | (477) 267 2000 | juan_ojeda82@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lauro Amador Medina | Hospital regional Alta especialidad BajÃo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Alta Especialidad Bajio | Recruiting | León | Guanajuato | 37660 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41522540 | Derived | Barrera Chavez ID, Viloria Alvarez JC, Zendejas Sanchez V, Rodriguez Esquivel A, Alvarez Salinas A, Amador Medina LF. Efficacy of Brentuximab-Vedotin Combined with PD-1 Inhibitors in Relapsed/Refractory Hodgkin Lymphoma with ASCT Consolidation and Maintenance Therapy: A Phase 2 Clinical Trial. Indian J Hematol Blood Transfus. 2026 Jan;42(1):93-99. doi: 10.1007/s12288-025-01986-0. Epub 2025 Feb 17. |
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We have plan to share participant data for metanalysis
request by researcher
request by researcher
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D000077594 | Nivolumab |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
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Brentuximab plus PD-1 blocked x 8 plus ASCT (PEAM condicioning) plus maintanance Brentuximab plus PD-1 x 8 cycles
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|
| 24 months |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |