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

Recruiting now · Phase 2

Conditions studied: Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, B-Cell Lymphoproliferative Disorder, Indolent Lymphoma

In brief

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)

Key facts

Study ID: NCT06986174
Run by: Shayna Sarosiek, MD
People needed: 30
Starts: 2025-11-21
Expected to finish: 2032-10-01
Last updated by the study team: 2025-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years
ECOG performance status ≤2
Clinicopathological diagnosis of Waldenström Macroglobulinemia
Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia. At least one of the following:
constitutional symptoms: recurrent fever, night sweats, fatigue or weight loss
progressive or symptomatic lymphadenopathy or splenomegaly
hemoglobin ≤10 g/dL
platelet count ≤100 k/uL
hyperviscosity syndrome
symptomatic peripheral neuropathy
systemic amyloidosis
renal insufficiency
symptomatic cryoglobulinemia
Serum IgM level ≥ 2 times the upper limit of normal
Participants must meet the following organ and marrow functions as defined below:
absolute neutrophil count ≥0.5 k/uL without growth factor within 7 days
platelet count ≥50 k/uL without platelet transfusion within 7 days
total bilirubin ≤1.5 times the upper limit of normal or ≤3 times the upper limit of normal with documented liver involvement, hemolysis or Gilbert's disease
AST (SGOT) and ALT (SGPT) ≤2.5 times the upper limit of normal or ≤5 times the upper limit of normal with documented liver involvement
Creatinine clearance ≥30 ml/min using Cockcroft/Gault equation
Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)
At least 2 prior lines of treatment for Waldenström Macroglobulinemia. Participants must either be BTK inhibitor exposed or not be a candidate for BTK therapy.
Women of childbearing potential: Females of childbearing potential (FCBP) will be required to use two highly effective forms of contraception simultaneously or will remain abstinent from heterosexual intercourse during the following periods related to this study:
while participating in the study; and 2) for at least three months (90 days) after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.

You may not qualify if…

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.
Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment. Patients who are hepatitis C RNA positive will be excluded.
Participants with chronic liver disease and hepatic impairment meeting Child-Pugh class B or C (Appendix B)
Participants who are pregnant, breast feeding, or planning to become pregnant while enrolled in this study or within 3 month after last study dose (2 weeks for breastfeeding)
Current CNS involvement by WM
Active alcohol or drug abuse
Concurrent administration of medications that are moderate or strong inhibitors or inducers of CYP3A within 14 days or 5 half-lives, whichever is shorter, prior to first dose of study drug.
Concurrent participation in another therapeutic clinical trial
History of another malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, or other adequately treated cancer currently in complete remission
Prior or ongoing clinically significant illness, including active infections requiring antibiotics, of medical condition that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results
Inability to swallow pills
Significant cardiovascular disease defined as:
Unstable angina, or
History of myocardial infarction within 6 months prior to planned start
Previously documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start; assessment of LVEF via echocardiogram or multigated acquisition (MUGA) scan during screening should be performed in selected patients as medically indicated, or
Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
Uncontrolled or symptomatic arrhythmias
Prolonged QT Interval with baseline QTc >480 msec using the Bazette formula
Ongoing, active infection.
Active bleeding requiring blood transfusion or other medical intervention. Participants requiring anticoagulation therapy are not excluded.

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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