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NCT04838652 Clinical Trial

Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma Clinical Trial

— Pembro-CORE  

Official title:
Phase II Trial of Pembrolizumab in Combination With Salvage Chemotherapy for First-relapsed or Refractory Classical Hodgkin Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04838652
Other study ID # Uni-Koeln-3942
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date December 2022
Est. completion date December 2026

Study information
Verified date August 2022
Source University of Cologne
Contact Michael Fuchs
Email ghsg@uk-koeln.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this trial is to develop an effective and well-tolerated regimen for treatment of r/r cHL by introducing the anti-PD-1 antibody pembrolizumab and adding it to well-established chemotherapy regimens (ICE, DHAP). Synergistic effects of conventional agents with checkpoint inhibition may facilitate a highly effective therapy with limited toxicity, which might eventually substitute the very toxic high-dose chemotherapy (HDCT).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 29
Est. completion date December 2026
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Histologically confirmed first relapse of cHL or primary refractory cHL Exclusion Criteria: - Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pembrolizumab plus Chemotherapy (ICE or DHAP)
Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP

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 Complete Metabolic Response Rate (CMR) The proportion of patients with a Deauville score of 1-3 in the centrally reviewed restaging after treatment with 1 x pembrolizumab + 4 cycles of pembrolizumab and chemotherapy combined (4x P-ICE or 2x P-ICE + 2x P-DHAP) after completion of P+chemotherapy, an average of 3 months
See also
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