Trials / Withdrawn
WithdrawnNCT04021082
CELTIC-1: A Phase 2B Study of Cerdulatinib in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL)
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- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Portola Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Cerdulatinib | Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies |
Timeline
- Start date
- 2019-11-15
- Primary completion
- 2022-12-31
- Completion
- 2023-06-01
- First posted
- 2019-07-16
- Last updated
- 2023-02-21
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04021082. Inclusion in this directory is not an endorsement.