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NCT Number: NCT06916416

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

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.

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Key information

Conditions

Classical Hodgkin Lymphoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pembrolizumab

Drug

6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy

Primary outcomes

  1. Progression Free Survival

    Time frame: PFS at 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Fuchs

CONTACT

[email protected]

+49221478 ext. 88160

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: PREFer

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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