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
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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