NCT04837859 Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
| NCT ID | NCT04837859 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Cologne |
| Condition | Classical Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-05-24 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the trial is to establish an individualized first-line treatment incorporating checkpoint inhibition for early-stage unfavorable cHL, which is effective and well tolerated.
Eligibility 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
Contact & Investigator
Paul Broeckelmann, Dr.
PRINCIPAL INVESTIGATOR
1st Department of Medicine, Cologne Universit Hospital
Frequently Asked Questions
Who can join the NCT04837859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Classical Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04837859 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04837859 currently recruiting?
Yes, NCT04837859 is actively recruiting participants. Contact the research team at ghsg@uk-koeln.de for enrollment information.
Where is the NCT04837859 trial being conducted?
This trial is being conducted at Cologne, Germany.
Who is sponsoring the NCT04837859 clinical trial?
NCT04837859 is sponsored by University of Cologne. The principal investigator is Paul Broeckelmann, Dr. at 1st Department of Medicine, Cologne Universit Hospital. The trial plans to enroll 120 participants.