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
| Registry | NCT05595447 |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | Hospital Regional de Alta Especialidad del Bajio (Other); collaborators: Universidad de Guanajuato |
| Conditions | Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult |
| Interventions | Brentuximab Vedotin 50 MG [Adcetris] (Drug) |
| Dates | start 2022-10-18, primary completion 2025-10-18 (estimated), completion 2025-10-18 (estimated), first posted 2022-10-27, last updated 2025-03-12 |
| Locations | 1 site in Mexico |
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All trials for Hodgkin Lymphoma All trials for Refractory Hodgkin Lymphoma All trials of Brentuximab Vedotin 50 MG [Adcetris]
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1 | Experimental | Drug: Brentuximab Vedotin 50 MG [Adcetris] | Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles |
Sex: All, ages: 15 Years to 90 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Regional Alta Especialidad Bajio | León, Guanajuato | Mexico | Recruiting |