CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This is an open-label, multinational study of cerdulatinib in patients with
relapsed/refractory PTCL dosed with cerdulatinb, designed to (1) Evaluate tumor response, (2)
Assess the safety and tolerability of cerdulatinib, (3) Evaluate duration of response (DUR),
progression free survival (PFS) and overall survival(OS), (4) Determine the PK properties of
cerdulatinib, (5) Evaluate the efficacy endpoints based on Lugano criteria per IRC and (6)To
assess the relationship between target expression (e.g., spleen tyrosine kinase [SYK], Janus
kinase [JAK]) and relevant anomalies (e.g., SYK-ITK translocation, mutations in the JAK/STAT
pathway) with clinical response.