Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma
NCT ID: NCT06916416
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2025-06-30
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pembrolizumab
All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy
Pembrolizumab
6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy
Interventions
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Pembrolizumab
6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy
Eligibility Criteria
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Inclusion Criteria
* Stage I-II without risk factors
* Large mediastinal mass
* Extranodal involvement
* Elevated erythrocyte sedimentation rate (ESR)
* Involvement of ≥ 3 nodal areas
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Dr. Dennis Eichenauer
Dr.
Principal Investigators
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Dennis Eichenauer, Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Central Contacts
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Other Identifiers
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2024-520138-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
Uni-Koeln-5450
Identifier Type: -
Identifier Source: org_study_id
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