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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Cologne Academic / other |
| Drugs / interventions | doxorubicin |
| Locations | 1 site (Cologne) |
| Status | Recruiting |
| Started | May 24, 2024 |
| Main results expected | May 2026 |
| Study ends | May 2028 |
| Registry record updated | July 26, 2024 |
| Trial ID | NCT04837859 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.
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Blood ctDNA testing to monitor treatment in children and young adults with classical Hodgkin lymphoma
This project tests whether a blood test that detects circulating tumor DNA can monitor treatment response and help predict relapse in children and young adults with classical Hodgkin lymphoma.
-
Sintilimab combined with AVD chemotherapy for treating pediatric Hodgkin lymphoma
This study is testing if a new immunotherapy combined with standard chemotherapy can help children and teens with low-to-intermediate risk Hodgkin lymphoma feel better and improve their treatment results.
-
Assessing Prognosis in Hodgkin Lymphoma
This study is trying to find better ways to predict how Hodgkin Lymphoma will progress in patients who have finished treatment or have had a relapse, using new tools and tests to help personalize their care.
-
Using Brentuximab Vedotin to treat newly diagnosed Classical Hodgkin Lymphoma in young patients
This study is testing if a new treatment with Brentuximab vedotin can help young patients with newly diagnosed classical Hodgkin lymphoma feel better while reducing the need for chemotherapy and radiation.
-
Healthy Lifestyle Plan for Lymphoma Survivors
This study is testing whether a special health plan that includes lifestyle changes and nutrition advice can help lymphoma survivors feel better after they've been in remission for a while.
-
Combining pembrolizumab with chemotherapy for relapsed Hodgkin lymphoma
This study is testing if adding pembrolizumab to standard chemotherapy can help people with relapsed Hodgkin lymphoma feel better and have fewer side effects.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.