Hodgkin Lymphoma
Conditions
Keywords
advanced stage, first line treatment, PD-1 inhibitor
Brief summary
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
DRUGPembrolizumab
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.
Sponsors
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 1 year |
Countries
Germany
Contacts
Primary ContactMichael Fuchs
Outcome results
None listed