New treatment approach for relapsed or 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
PHASE2; PHASE3 · Hospital Regional de Alta Especialidad del Bajio · NCT05595447
This study is testing a new treatment for people with relapsed or hard-to-treat Hodgkin lymphoma to see if combining certain therapies can help them live longer and feel better.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 90 Years |
| Sex | All |
| Sponsor | Hospital Regional de Alta Especialidad del Bajio (other) |
| Drugs / interventions | Brentuximab, immunotherapy |
| Locations | 1 site (León, Guanajuato) |
| Trial ID | NCT05595447 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a treatment strategy for patients with relapsed or refractory Hodgkin lymphoma who have high-risk factors. The approach combines Brentuximab Vedotin with PD-1 blockade followed by autologous stem cell transplantation and maintenance therapy. The study aims to evaluate progression-free survival and metabolic response rates in this patient population, addressing a significant gap in current treatment options. By focusing on immunotherapy, the trial seeks to improve outcomes while minimizing toxicity compared to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with relapsed or refractory Hodgkin lymphoma who have previously failed standard treatments.
Not a fit: Patients who have experienced severe toxicity from prior treatments or those who are unable to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment strategy could significantly improve survival rates and quality of life for patients with high-risk relapsed or refractory Hodgkin lymphoma.
How similar studies have performed: While the combination of Brentuximab and PD-1 blockade is promising, this specific treatment strategy for high-risk relapsed or refractory Hodgkin lymphoma is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
León, Guanajuato
- Hospital Regional Alta Especialidad Bajio — León, Guanajuato, Mexico (RECRUITING)
Study contacts
- Study coordinator: Lauro Fabián Amador, PhD
- Email: lafab2013@gmail.com
- Phone: 4772697907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hodgkin Lymphoma, Refractory Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult, refractory, relapsed, hodgkin lymphoma