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NCT06045195 Clinical Trial

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

Hodgkin Lymphoma Clinical Trial

— Pembro-FLASH  

Official title:
Phase II Trial of Pembrolizumab in First-Line Treatment of Advanced-Stage Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06045195
Other study ID # Uni-Koeln-4938
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 2024
Est. completion date January 2027

Study information
Verified date September 2023
Source University of Cologne
Contact Michael Fuchs
Phone +49221478
Email michael.fuchs@uk-koeln.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date January 2027
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pembrolizumab
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.

Locations
Country Name City State
Germany 1st Department of Medicine, Cologne University Hospital Cologne

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression free survival 1 year
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