Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma

Phase 2

Not yet recruiting

• Conditions: Classical Hodgkin Lymphoma
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT06916416
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pembrolizumab	Pembrolizumab	All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	PFS at 1 year