A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShayna Sarosiek, MD

About this trial

This study is being done to examine the safety and effectiveness of pacritinib as a possible treatment for participants with Waldenström macroglobulinemia (WM).

The name of the study drug involved in this study is:

-Pacritinib (a type of kinase inhibitor)

Eligibility criteria

Qualifiers

Age ≥18 years

ECOG performance status ≤2

Clinicopathological diagnosis of Waldenström Macroglobulinemia

constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss

Disqualifiers

Current history of uncontrolled HIV

Patients with a known history of HIV must have a viral load assessed for eligibility and must be on a stable antiretroviral regimen that can be administered concurrent with pacritinib.

Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below

Hepatitis B virus (HBV): Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Patients who are hepatitis B PCR positive will be excluded.

Trial design

Treatments tested in this trial

  • Pacritinib

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shayna Sarosiek, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Sobi, Inc.

Collaborator