Phase 2 Study on the Safety and Effectiveness of Pacritinib for Treating Relapsed or Hard-to-Treat Waldenström Macroglobulinemia

Sponsor: Shayna Sarosiek, MD

Sponsor score: 0

ClinicalTrials ID:NCT06986174

Provider View

This clinical trial is testing the safety and effectiveness of a drug called pacritinib for people with Waldenström macroglobulinemia (WM) that has returned or is not responding to treatment. Pacritinib is a type of targeted therapy that may help stop cancer cells from growing.

Patient Parameters

Program Overview

This study is exploring whether pacritinib, a drug that targets specific proteins in cancer cells, can be a safe and effective treatment for people with Waldenström macroglobulinemia (WM) that has come back or is difficult to treat. Pacritinib works by blocking proteins called JAK2 and IRAK1, which help cancer cells survive and grow. Although pacritinib is not yet approved for WM, it is approved for another condition called Myelofibrosis. Participants will undergo various tests and procedures, including blood tests, scans, and bone marrow biopsies, to monitor their health and the drug's effects. The study will last up to four years, with follow-up for two years or until a new treatment starts. About 30 people are expected to participate, and the study is supported by Sobi AG, Inc.

Description

This study involves taking pacritinib, a drug that targets cancer cells, to see if it can help people with Waldenström macroglobulinemia (WM) that has returned or is not responding to other treatments. Pacritinib blocks proteins that help cancer cells grow, potentially stopping or slowing down the disease. Participants will receive the drug for up to four years and will be monitored through regular visits, tests, and scans. The study aims to determine if pacritinib is safe and effective for treating WM. Participants will be followed for two years after treatment or until they start a new therapy. The study is open to about 30 participants and is funded by Sobi AG, Inc.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a diagnosis of Waldenström Macroglobulinemia (WM) with symptoms that require treatment, such as fever, night sweats, fatigue, weight loss, or other specific conditions.
  • Have tried at least two previous treatments for WM and either have been exposed to BTK inhibitors or are not suitable for BTK therapy.
  • Have a performance status score of 2 or less, meaning they are able to carry out all self-care but unable to carry out any work activities.
  • Have certain blood and organ function levels within specified limits.
  • Women of childbearing potential must use effective birth control during the study and for three months after.
  • Be able to understand and sign a consent form to participate.

Exclusion Criteria

  • Have uncontrolled HIV or active hepatitis B or C infections.
  • Have chronic liver disease with significant impairment.
  • Be pregnant, breastfeeding, or planning to become pregnant during the study or shortly after.
  • Have current involvement of the central nervous system by WM.
  • Have a history of alcohol or drug abuse.
  • Be taking certain medications that affect the liver or are part of another clinical trial.
  • Have a history of another cancer, except for certain types that have been treated and are in remission.
  • Have significant heart disease or other serious medical conditions that could affect participation.
  • Be unable to swallow pills or have ongoing infections or bleeding issues.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02115BostonMassachusetts

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