Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma
PREFer
2 other identifiers
interventional
50
0 countries
N/A
Brief Summary
By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2025
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 8, 2025
March 1, 2025
1 year
March 31, 2025
March 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
PFS at 1 year
Study Arms (1)
Pembrolizumab
EXPERIMENTALAll patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy
Interventions
6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy
Eligibility Criteria
You may qualify if:
- Histologically proven first diagnosis of cHL
- Stage I-II without risk factors
- Large mediastinal mass
- Extranodal involvement
- Elevated erythrocyte sedimentation rate (ESR)
- Involvement of ≥ 3 nodal areas
You may not qualify if:
- Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma,
- Prior cHL-directed treatment
- Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
- Prior or concurrent disease precluding protocol treatment (for details see section 4.2)
- Pregnancy or breastfeeding
- Non-compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis Eichenauer, Dr.
University Hospital of Cologne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 8, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2028
Last Updated
April 8, 2025
Record last verified: 2025-03