NCT05595447 Treatment Strategy for Relapsed/Refractory Hodgkin Lymphoma
| NCT ID | NCT05595447 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hospital Regional de Alta Especialidad del Bajio |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-10-18 |
| Primary Completion | 2025-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2022-10-18 with a primary completion date of 2025-10-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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?
Eligibility Criteria
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
Contact & Investigator
Lauro Amador Medina
STUDY DIRECTOR
Hospital regional Alta especialidad Bajío
Frequently Asked Questions
Who can join the NCT05595447 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 90 Years, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05595447 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05595447 currently recruiting?
Yes, NCT05595447 is actively recruiting participants. Contact the research team at lafab2013@gmail.com for enrollment information.
Where is the NCT05595447 trial being conducted?
This trial is being conducted at León, Mexico.
Who is sponsoring the NCT05595447 clinical trial?
NCT05595447 is sponsored by Hospital Regional de Alta Especialidad del Bajio. The principal investigator is Lauro Amador Medina at Hospital regional Alta especialidad Bajío. The trial plans to enroll 20 participants.