Actively Recruiting
A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
Led by Shayna Sarosiek, MD · Updated on 2025-12-05
30
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
S
Shayna Sarosiek, MD
Lead Sponsor
S
Sobi, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years
- ECOG performance status 2
- Diagnosed with Waldenstr�om Macroglobulinemia
- Symptomatic disease that meets treatment criteria including at least one of: constitutional symptoms (fever, night sweats, fatigue, weight loss), progressive 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 at least 2 times the upper limit of normal
- Adequate organ and marrow function as defined by neutrophil count 0.5 k/uL, platelet count 50 k/uL, bilirubin 1.5 times upper limit of normal (or 3 with specific conditions), AST and ALT 2.5 times upper limit of normal (or 5 with specific conditions), creatinine clearance 30 ml/min
- Ability and willingness to provide informed consent
- At least 2 prior lines of treatment for Waldenstr�om Macroglobulinemia
- Must be BTK inhibitor exposed or not a candidate for BTK therapy
- Women of childbearing potential must use two highly effective contraception methods or remain abstinent during the study and for 3 months after
You will not qualify if you...
- Current uncontrolled HIV infection
- Known HIV with unstable viral load or not on stable antiretroviral therapy compatible with pacritinib
- Active hepatitis B or C infection based on specific testing criteria
- Chronic liver disease with Child-Pugh class B or C
- Pregnant, breastfeeding, or planning pregnancy during or shortly after the study
- Central nervous system involvement by WM
- Active alcohol or drug abuse
- Use of moderate or strong CYP3A inhibitors or inducers within 14 days or 5 half-lives before first dose
- Participation in another therapeutic clinical trial
- History of other malignancies except certain treated localized cancers in remission
- Significant medical illnesses, active infections requiring antibiotics, or conditions affecting safety or study drug metabolism
- Inability to swallow pills
- Significant cardiovascular disease including unstable angina, recent myocardial infarction, low heart ejection fraction, severe cardiac disease, uncontrolled arrhythmias
- Prolonged QT interval over 480 msec
- Ongoing active infections or active bleeding requiring medical intervention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Shayna Sarosiek, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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