Classical Hodgkin Lymphoma
Conditions
Brief summary
By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.
Interventions
DRUGPembrolizumab
6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy
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 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven first diagnosis of cHL * Stage I-II without risk factors * Large mediastinal mass * Extranodal involvement * Elevated erythrocyte sedimentation rate (ESR) * Involvement of ≥ 3 nodal areas
Exclusion criteria
* Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma, * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | PFS at 1 year |
Contacts
Primary ContactMichael Fuchs
Outcome results
None listed