Study on Pacritinib for Treating Relapsed or Hard-to-Treat T-cell Lymphoproliferative Disorders

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04858256

Provider View

This clinical trial is testing the effectiveness of the drug pacritinib in patients with T-cell lymphoproliferative disorders that have returned after treatment or have not responded to previous treatments.

Patient Parameters

Program Overview

The purpose of this study is to find out how well the drug pacritinib works in treating people with T-cell lymphoproliferative disorders that have either come back after treatment or have not responded to previous treatments. Participants will take pacritinib pills twice a day until they need to stop for any reason. The study includes different groups based on the type of T-cell disorder, such as Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma.

Description

Participants in this study will take pacritinib, a medication given as a pill, twice a day. The study is divided into four groups based on the type of T-cell disorder: Peripheral T-Cell Lymphoma (PTCL), Angioimmunoblastic T-cell Lymphoma (AITL), Cutaneous T-Cell Lymphoma (CTCL), and other less common types of PTCL. The goal is to see if pacritinib can help control these disorders when other treatments have not worked or the disease has returned.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent.
  • Have a performance status score of 2 or less, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a confirmed diagnosis of a specific type of T-cell disorder as per medical guidelines.
  • The disease must have returned or not responded to previous treatments.
  • Have good organ and blood function as per study requirements.
  • Able to take oral medication without needing to crush or dissolve the tablets.
  • Able to communicate well with the study team and expected to live at least 3 more months.

Exclusion Criteria

  • Have a significant illness or medical condition that could affect the study.
  • Pregnant or breastfeeding women.
  • Not willing or able to use contraception during the study unless certain conditions apply.
  • Have uncontrolled illnesses, such as active infections needing IV treatment, severe heart failure, recent heart attack, or severe liver problems.
  • Have known infections like HIV, Hepatitis B, or Hepatitis C.
  • Have had major surgery recently or have not recovered from recent treatments.
  • Using certain medications that affect the heart or interact with pacritinib.
  • Have a history of significant bleeding or need blood thinners.
  • Have had a stem cell transplant from a donor.

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