Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Refractory Hodgkin Lymphoma | Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Relapsed Hodgkin's Disease, Adult | Adult Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab Vedotin 50 MG [Adcetris] | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1
- description
- Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles
- interventionNames
- Drug: Brentuximab Vedotin 50 MG [Adcetris]
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 24 months
- description
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Secondary outcomes (2)
- measure
- complete remission
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBarrera 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. PMID 41522540