Status:
RECRUITING
Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma
Lead Sponsor:
University of Cologne
Conditions:
Classical Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed Description
Programmed cell death protein-1 (PD-1) blockade is highly effective and well tolerated in relapsed or refractory cHL and has also demonstrated efficacy in the first-line treatment of cHL in combinatio...
Eligibility Criteria
Inclusion
- 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):
- large mediastinal mass
- extranodal lesion(s)
- elevated erythrocyte sedimentation rate
- ≥ 3 nodal areas
Exclusion
- Presence of nodular-lymphocyte predominant Hodgkin lymphoma, grey-zone lymphoma and/or central nervous system involvement of lymphoma
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04837859
Start Date
May 24 2024
End Date
May 1 2028
Last Update
July 26 2024
Active Locations (1)
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1
1st Department of Medicine, Cologne University Hospital
Cologne, Germany