Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-30 @ 5:38 PM
Study NCT ID:
NCT04858256
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
Phase 2, Open Label, Multicenter Study of Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.
Detailed Description:
Patients will receive single-agent treatment with pacritinib 200mg orally twice daily until any condition for treatment discontinuation has been met. Patients will be enrolled into one of four cohorts: Peripheral T-Cell Lymphoma, not otherwise specified (PTCL, NOS) (cohort 1); angioimmunoblastic T-cell lymphoma/follicular helper T-cell (AITL/TFH) PTCL (cohort 2); Cutaneous T-Cell Lymphoma (CTCL) - mycosis fungoides (MF) and Sezary syndrome (SS) (cohort 3); and other eligible, less common PTCL subtypes (cohort 4).
14NOV2025- Updates were made to the inclusion and exclusion criteria to align with the pacritinib IB v19 and the funders guidance.
14NOV2025- Updates were made to the inclusion and exclusion criteria to align with the pacritinib IB v19 and the funders guidance.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA265929 | NIH | None | https://reporter.nih.gov/quic… | View |
| HUM00184365 | OTHER | University of Michigan | View | |
| HCRN LYM21-544 | OTHER | Hoosier Cancer Research Network | View |