Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 15 to 90

New treatment approach for relapsed or refractory Hodgkin lymphoma

Official title: 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

Run by Hospital Regional de Alta Especialidad del Bajio · NCT05595447 · Data updated 2026-11-12

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

PhasePhase2; Phase3
Study typeInterventional
Ages15 Years to 90 Years
SexAll
Enrollment20 (estimated)
SponsorHospital Regional de Alta Especialidad del Bajio
Academic / other
Drugs / interventionsBrentuximab, immunotherapy
Locations1 site (León, Guanajuato)
StatusRecruiting
StartedOctober 18, 2022
Main results expectedOctober 18, 2025
Study endsOctober 18, 2025
Registry record updatedMarch 12, 2025
Trial IDNCT05595447 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 90 with relapsed or refractory Hodgkin lymphoma who have previously failed standard treatments.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hospital Regional Alta Especialidad Bajio
    León, Guanajuato, Mexico
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.