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

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NCT-Nummer:
NCT04838652

Studienbeginn:
Dezember 2022

Letztes Update:
08.08.2022

Wirkstoff:
Pembrolizumab plus Chemotherapy (ICE or DHAP)

Indikation (Clinical Trials):
Lymphoma, Hodgkin Disease

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
University of Cologne

Collaborator:
-

Studienleiter

Andreas Engert, Prof.
Principal Investigator
1st Department of Medicine, Cologne Universit Hospital

Kontakt

Michael Fuchs
Kontakt:
E-Mail: ghsg@uk-koeln.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

1st Department of Medicine, Cologne University Hospital
Cologne
(Nordrhein-Westfalen)
Germany» Google-Maps

Studien-Informationen

Brief 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).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed first relapse of cHL or primary refractory cHL

Exclusion Criteria:

- Nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma

Studien-Rationale

Primary outcome:

1. Complete Metabolic Response Rate (CMR) (Time Frame - after completion of P+chemotherapy, an average of 3 months):
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)

Geprüfte Regime

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

Quelle: ClinicalTrials.gov