Phase 2, Open Label, Multicenter Study of Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms
University of Michigan Rogel Cancer Center
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.
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 wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Selected Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and the willingness to sign a written informed consent. 2. ECOG performance status ≤ 2 3. A histologically confirmed diagnosis, per the WHO 2016 classification, of any PTCL or CTCL subtype listed in the protocol. 4. Relapsed or refractory disease. Refractory disease is defined as progression during treatment or recur…
Interventions
- DrugPacritinib
Pacritinib will be dosed at 200mg twice daily.
Locations (6)
- City of HopeDuarte, California
- Moffitt Cancer CenterTampa, Florida
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan
- Duke Cancer InstituteDurham, North Carolina
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania