CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)

ALCL Clinical Trial

Official title: CELTIC-1 (Clinical Evaluation of T-cell NHL With Cerdulatinib): A Phase 2b, Open Label, Multidose, Multinational Study of Cerdulatinib (PRT062070) in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• AITL
• ALCL
• EATL I,II
• Follicular T-cell Lymphoma (FTCL)
• HSTCL
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• MEITL, EATL Type II
• Nasal Lymphoma
• Nodal Lymphomas of T Follicular Helper (TFH)
• Peripheral T-Cell Lymphoma (PTCL NOS)

• NCT number: NCT04021082
• Study type: Interventional
• Source: Alexion Pharmaceuticals
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 15, 2019
• Completion date: June 1, 2023