Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
NCT ID: NCT06045195
Last Updated: 2025-04-06
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
40 participants
INTERVENTIONAL
2025-08-31
2029-01-31
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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Treatment
Pembrolizumab + BrECADD
Pembrolizumab
As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and BrECADD (P-BrECADD). Response to induction therapy will be measured after 1x P (PET-1) and after 1x P + 2x P-BrECADD (PET-3).
Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two further cycles of P-BrECADD while participants with a positive PET-3 will receive four further cycles of P-BrECADD. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.
Interventions
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Pembrolizumab
As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and BrECADD (P-BrECADD). Response to induction therapy will be measured after 1x P (PET-1) and after 1x P + 2x P-BrECADD (PET-3).
Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two further cycles of P-BrECADD while participants with a positive PET-3 will receive four further cycles of P-BrECADD. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.
Eligibility Criteria
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Inclusion Criteria
* advanced stage classical Hodgkin Lymphoma
* no previous treatment for cHL
Exclusion Criteria
* Chemotherapy or radiotherapy in medical history
* Prior or concurrent disease that prevents treatment according to protocol
18 Years
60 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Prof. Dr. Peter Borchmann
Prof.
Principal Investigators
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Peter Borchmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
1st Department of Medicine, Cologne University Hospital
Locations
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1st Department of Medicine, Cologne University Hospital
Cologne, , Germany
Countries
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Central Contacts
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Other Identifiers
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Uni-Koeln-4938
Identifier Type: -
Identifier Source: org_study_id
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