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)
Age ≥18 years
ECOG performance status ≤2
Clinicopathological diagnosis of Waldenström Macroglobulinemia
constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
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.
Single group
Pacritinib
DrugKinase inhibitor, capsule, taken orally per protocol.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR) on treatment based on IWWM-11 criteria.
Complete Response Rate
Complete response rate was defined as the percentage of participants achieving complete response (CR) on treatment based on IWWM-11 criteria, defined as having resolution of WM related symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly. A complete response requires reconfirmation demonstrating normal serum IgM levels, and absence of IgM paraprotein by immunofixation by a measurement repeated at least 2 weeks later.
Very Good Partial Response Rate
Very good partial response rate was defined as the percentage of participants achieving very good partial response (VGPR) on treatment based on IWWM-11 criteria, defined as ≥90% reduction in serum IgM levels, or normalization of serum IgM levels with persistent IgM monoclonal spike in SPEP or immunofixation.
Partial Response Rate
Partial response rate was defined as the percentage of participants achieving partial response (PR) on treatment based on IWWM-11 criteria, Partial response (PR) is defined as achieving a ≥50% to \<90% reduction in serum IgM levels.
Minimal Response Rate
Minimal response rate was defined as the percentage of participants achieving minimal response (MR) on treatment based on IWWM-11 criteria, defined as ≥25 to \<50% reduction in serum IgM levels.
Click on the lead sponsor to view all of their trials.
Shayna Sarosiek, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Sobi, Inc.
Collaborator
