NCT05595447RecruitingPhase 2/3
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 · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Oct 2022
- Start date
- 18 Oct 2022
- Primary completion date
- 18 Oct 2025
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Diseases
- Hodgkin lymphoma, Childhood cancers
- NCT number
- NCT05595447
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 20
- From 18 Oct 2022 to the primary completion date, 18 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Voluntary withdrawal from the study.
- Develop grade 3 or 4 toxicity according to the INH scale.
- Loss of follow-up
Who the study is looking for
- Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.
- Age ≥ 18 years and ≤ 90 years.
- 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
- 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.
Age in the registry: 15 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Regional Alta Especialidad Bajio Coordinator of this site? Confirm its status | León | Mexico | Recruiting |
Related publications
- 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 · PMID 41522540
This page is information, not medical advice. Discuss any trial with your doctor.