Back to resultsPembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma (Pembro-FLASH)
Primary Purpose
Hodgkin Lymphoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring advanced stage, first line treatment, PD-1 inhibitor
Eligibility Criteria
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
Sites / Locations
- 1st Department of Medicine, Cologne University Hospital
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT06045195
First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
University of Cologne
1. Study Identification
Unique Protocol Identification Number
NCT06045195
Brief Title
Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Acronym
Pembro-FLASH
Official Title
Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
advanced stage, first line treatment, PD-1 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
As induction therapy, all participants will receive one dose of single-agent pembrolizumab (P) followed by two cycles of chemo-immunotherapy consisting of pembrolizumab and an eBEACOPP variant without bleomycin (P-EACOPP). Response to induction therapy will be measured after P-mono (PET-1; only for scientific purposes) and after completion of 1x P and 2x P-EACOPP (PET-3).
Further systemic treatment is PET-3-guided. Complete metabolic responses will be consolidated with two cycles of P-EACOPP while participants with a positive PET-3 will receive four cycles of P-EACOPP. PET-positive lesions after completion of chemo-immunotherapy will be recommended for consolidating radiotherapy according to standard of care.
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Fuchs
Phone
+49221478
Ext
88160
Email
michael.fuchs@uk-koeln.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Borchmann, Prof.
Organizational Affiliation
1st Department of Medicine, Cologne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Department of Medicine, Cologne University Hospital
City
Cologne
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma
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