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

March 31, 2025 updated by: Dr. Dennis Eichenauer, University of Cologne
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab
All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy
Drug: Pembrolizumab
6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: PFS at 1 year
PFS at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • Principal Investigator: Dennis Eichenauer, Dr., University Hospital of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

March 31, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-5450
  • 2024-520138-31-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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