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

NCT04021082 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Cerdulatinib

Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies

Sponsors & Collaborators

  • Portola Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2022-12-31
Completion
2023-06-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021082 on ClinicalTrials.gov