Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Hodgkin Lymphoma. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Overview
The primary objective of this trial is to estimate efficacy of the novel regimen. The primary endpoint is the 1-year PFS rate after treatment with one dose of pembrolizumab followed by four to six cycles of chemo-immunotherapy with P-BrECADD, and PET-guided radiotherapy as per standard of care
Interventions
- Drug 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 cy
Primary outcome measures
- progression free survival [Time frame: 1 year]
Eligibility criteria
Main Inclusion Criteria:
- age 18-60
- advanced stage classical Hodgkin Lymphoma
- no previous treatment for cHL
Main Exclusion Criteria:
- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
- Chemotherapy or radiotherapy in medical history
- Prior or concurrent disease that prevents treatment according to protocol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- 1st Department of Medicine, Cologne University Hospital — Cologne
Identifiers
NCT: NCT06045195 · Uni-Koeln-4938