Pembro-FLASH: Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

• Sponsor: University of Cologne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06045195
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The aim of the trial is to establish a new regimen with Pembrolizumab and chemotherapy in the first line treatment of patients with advanced stage classical Hodgkin Lymphoma

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma	Drug: Pembrolizumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jan 1, 2025
• Anticipated Study Completion Date: Jan 1, 2027

Outcome Measures

Primary Outcome Measures

1. progression free survival [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Inclusion Criteria:

• age 18-60

• advanced stage classical Hodgkin Lymphoma

• no previous treatment for cHL

Main Exclusion Criteria:

• Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

• Chemotherapy or radiotherapy in medical history

• Prior or concurrent disease that prevents treatment according to protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1st Department of Medicine, Cologne University Hospital	Cologne		Germany

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Peter Borchmann, Prof., 1st Department of Medicine, Cologne University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dr. Peter Borchmann, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT06045195
• Other Study ID Numbers: Uni-Koeln-4938
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Dr. Peter Borchmann, Prof., University of Cologne: advanced stage; first line treatment; PD-1 inhibitor
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Pembrolizumab

Study Results

No Results Posted as of Sep 21, 2023