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

NCT ID: NCT06916416

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2028-06-30

Brief Summary

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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

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Conditions

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Classical Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab

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

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

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

Interventions

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Pembrolizumab

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Dr. Dennis Eichenauer

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis Eichenauer, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Central Contacts

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Michael Fuchs

Role: CONTACT

+49221478 ext. 88160

Other Identifiers

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2024-520138-31-00

Identifier Type: CTIS

Identifier Source: secondary_id

Uni-Koeln-5450

Identifier Type: -

Identifier Source: org_study_id

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