OncoMatch/Clinical Trials/NCT06303193
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Is NCT06303193 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies pacritinib for myelodysplastic syndromes.
Treatment: pacritinib — Background: Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed. Objective: To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN. Eligibility: Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone. Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants. Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years. Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Performance status
ECOG/KARNOFSKY/LANSKY 0–1
For participants >= 16 years of age, ECOG performance status < 2 (Karnofsky >= 60%). For participants < 16 years of age, Lansky >= 60%
Lab requirements
Blood counts
PT and PTT: <= 1.5 X institutional upper limit of normal, except in the setting of PTT elevation due to lupus anticoagulant
Kidney function
Creatinine clearance: >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
Liver function
Total bilirubin: <= 1.5 X institutional upper limit of normal OR <= 3 x institutional upper limit of normal in participants with Gilbert's syndrome; AST(SGOT)/ALT(SGPT): <= 2.5 X institutional upper limit of normal
Participants must have adequate organ function as defined below: Total bilirubin: <= 1.5 X institutional upper limit of normal OR <= 3 x institutional upper limit of normal in participants with Gilbert's syndrome; AST(SGOT)/ALT(SGPT): <= 2.5 X institutional upper limit of normal; Creatinine clearance: >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal; PT and PTT: <= 1.5 X institutional upper limit of normal, except in the setting of PTT elevation due to lupus anticoagulant
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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