OncoMatch/Clinical Trials/NCT07033598
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
Is NCT07033598 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pacritinib and Hydroxyurea for leukemia, myelomonocytic, chronic.
Treatment: Pacritinib · Hydroxyurea — The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are: * Does pacritinib improve disease control compared to hydroxyurea? * What medical problems do participants have when taking pacritinib or hydroxyurea? Researchers will compare pacritinib to hydroxyurea to see if pacritinib is more effective and better tolerated in people with advanced proliferative chronic myelomonocytic leukemia. Participants will be randomly assigned to receive either pacritinib twice a day or hydroxyurea for up to 48 weeks. After treatment ends, participants will be followed for up to one year.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: JAK inhibitor
Prior systemic treatment with any JAK inhibitor.
Cannot have received: hypomethylating agent
Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
Cannot have received: cytotoxic chemotherapy
Exception: hydroxyurea allowed
Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
Cannot have received: allogeneic hematopoietic stem cell transplant
Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before enrollment.
Lab requirements
Blood counts
absolute neutrophil count ≥0.5 × 10⁹/L, PT and PTT ≤1.5 × ULN, platelet count <100 × 10⁹/L (advanced disease criterion)
Kidney function
creatinine clearance >30 mL/min
Liver function
AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome)
Cardiac function
QTcF >450 ms (men) or >470 ms (women); QTcF up to 480 ms allowed if QRS >100 ms. CTCAE Grade ≥3 cardiac event within 3 months before enrollment. Symptomatic heart failure with limitations on ordinary activity.
Adequate organ function: AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome), creatinine clearance >30 mL/min, absolute neutrophil count ≥0.5 × 10⁹/L, PT and PTT ≤1.5 × ULN. QTcF >450 ms (men) or >470 ms (women); QTcF up to 480 ms allowed if QRS >100 ms. CTCAE Grade ≥3 cardiac event within 3 months before enrollment. Symptomatic heart failure with limitations on ordinary activity.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Winship Cancer Institute at Emory · Atlanta, Georgia
- Mayo Clinic Rochester · Rochester, Minnesota
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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