Classical Hodgkin Lymphoma
Conditions
Brief summary
The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).
Interventions
DRUGPembrolizumab plus Chemotherapy (ICE or DHAP)
Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP
Sponsors
University of Cologne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed first relapse of cHL or primary refractory cHL
Exclusion criteria
* Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Metabolic Response Rate (CMR) | after completion of P+chemotherapy, an average of 3 months | The proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP) |
Countries
Germany
Contacts
Primary ContactMichael Fuchs
Outcome results
None listed