Individualized immunotherapy for early-stage Hodgkin lymphoma
Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
PHASE2 · University of Cologne · NCT04837859
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne (other) |
| Drugs / interventions | doxorubicin |
| Locations | 1 site (Cologne) |
| Trial ID | NCT04837859 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown success with PD-1 blockade in Hodgkin lymphoma, indicating a promising approach for this patient population.
Eligibility criteria
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 this trial is running
Cologne
- 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
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: Classical Hodgkin Lymphoma