Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Individualized immunotherapy for early-stage Hodgkin lymphoma

Official title: Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma

Run by University of Cologne · NCT04837859 · Data updated 2026-11-12

This study is testing a personalized treatment using a new drug for young people with early-stage Hodgkin lymphoma to see if it can help them avoid harsh chemotherapy and improve their quality of life.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorUniversity of Cologne
Academic / other
Drugs / interventionsdoxorubicin
Locations1 site (Cologne)
StatusRecruiting
StartedMay 24, 2024
Main results expectedMay 2026
Study endsMay 2028
Registry record updatedJuly 26, 2024
Trial IDNCT04837859 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18-60 with a first diagnosis of treatment-naïve early-stage unfavorable classical Hodgkin lymphoma.

Probably not a fit

Patients with nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma, or central nervous system involvement of lymphoma will 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 trial aims to establish a personalized first-line treatment for early-stage unfavorable classical Hodgkin lymphoma (cHL) using checkpoint inhibition. The approach focuses on the use of Tislelizumab, a PD-1 blockade, which has shown effectiveness in relapsed cHL and may reduce the need for conventional chemotherapy and radiotherapy. By targeting patients who achieve early metabolic complete remission, the study seeks to minimize treatment-related side effects and improve quality of life for predominantly young patients. The trial will evaluate the safety and efficacy of this treatment strategy in a defined patient population.

Why it matters

Potential benefit: If successful, this approach could provide a safer, chemotherapy-free treatment option for patients with early-stage unfavorable classical Hodgkin lymphoma.

How similar studies have gone: Previous studies have shown success with PD-1 blockade in Hodgkin lymphoma, indicating a promising approach for this patient population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 18-60 for the main trial cohort
* Age ≥ 61 years and eligible for AVD as determined by CIRS-G score and investigator for the exploratory cohort
* First diagnosis of treatment-naïve cHL
* Early-stage unfavorable disease (i.e. stage IA, IB and IIA with risk factors a-d, stage IIB with risk factors c-d):

  1. large mediastinal mass
  2. extranodal lesion(s)
  3. elevated erythrocyte sedimentation rate
  4. ≥ 3 nodal areas

     Exclusion Criteria:
* Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma

Where it's running

  • 1st Department of Medicine, Cologne University Hospital
    Cologne, Germany
    Recruiting

Study contacts

  • Principal investigator: Paul Broeckelmann, Dr. — 1st Department of Medicine, Cologne Universit Hospital
  • Study coordinator: Michael Fuchs
  • Email: ghsg@uk-koeln.de
  • Phone: +49221478

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.