Study Comparing Pacritinib and Hydroxyurea for Advanced Chronic Myelomonocytic Leukemia
Sponsor: Theradex
ClinicalTrials ID:NCT07033598
This clinical trial is testing whether the drug pacritinib is more effective than hydroxyurea in treating adults with advanced chronic myelomonocytic leukemia (CMML). The study will also look at the side effects of each treatment.
Patient Parameters
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Program Overview
The purpose of this study is to find out if pacritinib works better than hydroxyurea in controlling advanced chronic myelomonocytic leukemia (CMML) in adults. Researchers want to know if pacritinib can improve disease control and what side effects might occur with each treatment. Participants will be randomly assigned to receive either pacritinib or hydroxyurea for up to 48 weeks. After the treatment period, participants will be monitored for up to one year to track their health and any changes in their condition.
Description
This study involves comparing two treatments, pacritinib and hydroxyurea, for adults with advanced chronic myelomonocytic leukemia (CMML). About 66 participants will be randomly divided into two groups: one group will receive pacritinib, and the other will receive hydroxyurea. The treatment will last up to 48 weeks. If participants do not benefit from their assigned treatment by Week 24, they may switch to pacritinib if they meet certain criteria. After the treatment ends, participants will be followed for up to one year to monitor their overall health and survival. An independent committee will review the safety of the treatments regularly.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic myelomonocytic leukemia (CMML) with less than 10% bone marrow blasts and less than 5% peripheral blood blasts.
- High white blood cell count (13 or more).
- Advanced disease with at least one of the following: enlarged spleen, high symptom score, or low platelet count.
- Good overall health with a performance status of 2 or less.
- Adequate organ function based on specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
Exclusion Criteria
- Active cancer diagnosed within the past 2 years, except for certain non-invasive cancers.
- Recent stem cell transplant or need for immunosuppressive therapy.
- Likely to have a stem cell transplant within 6 months.
- Previous treatment with JAK inhibitors.
- Recent treatment with certain chemotherapy or participation in another study.
- Use of certain medications that affect blood clotting or the liver.
- Recent significant bleeding or heart problems.
- Uncontrolled infections or liver disease.
- Active hepatitis B or C, or uncontrolled HIV.
- Allergy to pacritinib or its ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Winship Cancer Institute at Emory | 30322 | Atlanta | Georgia |
| Mayo Clinic Rochester | 55905 | Rochester | Minnesota |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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