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New treatment option for Leukemia, Myelomonocytic, Chronic
Official title Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
ClinicalTrials.gov ID: NCT07033598
What this study is testing
What is Pacritinib?
Pacritinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for leukemia, myelomonocytic, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of CMML-1 (5th WHO classification), with \<10% bone marrow blasts on morphology and \<5% peripheral blood blasts.
- Proliferative disease, defined as white blood cell count ≥13 × 10⁹/L.
- Advanced disease, defined as at least one of the following features during screening: spleen palpable ≥5cm below the lower costal margin in the...
- ECOG performance status ≤2.
- Adequate organ function: AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome), creatinine clearance \>30...
You likely can't join if
- Active malignancy diagnosed within the past 2 years, except for curatively treated non-invasive cancers (e.g., basal/squamous cell skin cancer...
- Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before...
- Likely to undergo allogeneic hematopoietic stem cell transplant within 6 months, per investigator assessment.
- Prior systemic treatment with any JAK inhibitor.
- Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
- Participation in another treatment study or use of experimental therapy within 28 days or 5 half-lives, whichever is longer.
See the full eligibility criteria
- Diagnosis of CMML-1 (5th WHO classification), with \<10% bone marrow blasts on morphology and \<5% peripheral blood blasts.
- Proliferative disease, defined as white blood cell count ≥13 × 10⁹/L.
- Advanced disease, defined as at least one of the following features during screening: spleen palpable ≥5cm below the lower costal margin in the midclavicular line; TSS ≥20; or platelet count \<100 × 10⁹/L. For...
- ECOG performance status ≤2.
- 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.
- Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and, along with male participants, must agree to use a highly effective method of contraception from the first...
- Active malignancy diagnosed within the past 2 years, except for curatively treated non-invasive cancers (e.g., basal/squamous cell skin cancer, low-risk prostate cancer on stable endocrine therapy with PSA stable ≥3...
- Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before enrollment.
- Likely to undergo allogeneic hematopoietic stem cell transplant within 6 months, per investigator assessment.
- Prior systemic treatment with any JAK inhibitor.
- Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
- Participation in another treatment study or use of experimental therapy within 28 days or 5 half-lives, whichever is longer.
- Use of hematologic support drugs within 28 days prior to enrollment. Supportive care permitted.
- Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before enrollment, whichever is shorter.
- Use of systemic anticoagulants or antiplatelets (except aspirin ≤100 mg/day) within 14 days prior. Therapeutic anticoagulation allowed if stable for ≥90 days without bleeding events.
- CTCAE Grade ≥2 bleeding within 3 months prior to enrollment, unless due to a reversible cause (e.g., trauma, surgery).
- QTcF \>450 ms (men) or \>470 ms (women); QTcF up to 480 ms allowed if QRS \>100 ms. QTcF may be repeated if affected by reversible factors.
- CTCAE Grade ≥3 cardiac event within 3 months before enrollment.
- Symptomatic heart failure with limitations on ordinary activity.
- Uncontrolled infection at study entry.
- Moderate/severe hepatic impairment (Child-Pugh B or C), or active viral hepatitis:
- HBV: Exclude if HBsAg+ or HBV DNA detectable. HBV antiviral therapy allowed if HBV DNA undetectable.
- HCV: Allowed if HCV Ab+ but RNA negative.
- Uncontrolled HIV or detectable viral load while on antiretrovirals.
- Known hypersensitivity to pacritinib or its excipients (microcrystalline cellulose, polyethylene glycol, magnesium stearate).
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Rochester, Minnesota, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Atlanta, Georgia, United States; Rochester, Minnesota, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.