| Registry | NCT06916416, acronym PREFer |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | University of Cologne (Other) |
| Conditions | Classical Hodgkin Lymphoma |
| Interventions | Pembrolizumab (Drug) |
| Dates | start 2025-06-01 (estimated), primary completion 2026-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2025-04-08, last updated 2025-04-08 |
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All trials for Classical Hodgkin Lymphoma All trials of Pembrolizumab
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Pembrolizumab | Experimental | Drug: Pembrolizumab | All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy |
Sex: All, ages: 18 Years to 75 Years
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