NCT04858256

Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

Phase 2, Open Label, Multicenter Study of Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-Cell Neoplasm
• Lymphoproliferative Disorders

Interventions

Type	Name	Description
DRUG	Pacritinib	Pacritinib will be dosed at 200mg twice daily.

Timeline

• Start date: 2023-03-29
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2021-04-26
• Last updated: 2026-01-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study