Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04858256

Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

Led by University of Michigan Rogel Cancer Center · Updated on 2026-01-29

100

Participants Needed

6

Research Sites

292 weeks

Total Duration

On this page

Sponsors

U

University of Michigan Rogel Cancer Center

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The main purpose of this study is to determine the effectiveness of the study drug pacritinib in people with relapsed or refractory lymphoproliferative disorders.

CONDITIONS

Official Title

Pacritinib in Relapsed/Refractory T-cell Lymphoproliferative Neoplasms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent and HIPAA authorization before registration
  • ECOG performance status of 0 to 2
  • Histologically confirmed diagnosis of any listed peripheral or cutaneous T-cell lymphoma subtype
  • Relapsed or refractory disease as defined in the protocol
  • Adequate organ and blood function as detailed in the protocol
  • Availability of sufficient archival tissue or fresh biopsy tissue as required
  • HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
  • Patients with controlled hepatitis B or cured/controlled hepatitis C virus infection
  • Ability to take oral medication without crushing, dissolving, or chewing tablets
  • Anticipated life expectancy of at least 3 months and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • History of or current serious illness or laboratory abnormality that could affect study conduct
  • Pregnant or breastfeeding women
  • Unwillingness or inability to use effective contraception during and after treatment
  • Uncontrolled infections requiring intravenous antibiotics
  • Symptomatic congestive heart failure or ejection fraction below 45%
  • Unstable angina, unstable cardiac arrhythmia, recent heart attack, stroke, or intracranial hemorrhage within 6 months
  • Moderate to severe liver impairment
  • Psychiatric or social conditions limiting study compliance
  • Major surgery within 21 days before starting therapy
  • Less than 14 days since last radiation or chemotherapy or insufficient recovery from treatment toxicities
  • Use of systemic steroids above prednisone 10 mg/day
  • Prior treatment with pacritinib
  • Use of medications increasing bleeding risk except low-dose aspirin
  • History of significant bleeding or bleeding disorders within past 3 months
  • Allergy to pacritinib or related compounds
  • Treatment with strong CYP3A4 inducers or inhibitors without appropriate washout
  • Uncontrolled diarrhea or gastrointestinal/metabolic conditions affecting oral drug absorption
  • Prior allogeneic stem-cell transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

2

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Not Yet Recruiting

3

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

4

Duke Cancer Institute

Durham, North Carolina, United States, 27710

Actively Recruiting

5

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43202

Actively Recruiting

6

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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