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 |
Trial Parameters
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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