Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02410551
Eligibility Criteria:
Inclusion Criteria:
1. Patients with Idiopathic Myelofibrosis or Myelofibrosis secondary to Polycythemia Vera or Essential Thrombocythemia.
2. Patients 18 years to less than or equal to 70 years.
3. Patients wanting to pursue transplant.
4. Patients must have a Zubrod PS equal or less than 2.
5. Calculated creatinine clearance greater than 50ml/min. using the Cockcroft-Gault equation.
6. Ejection fraction equal or above 40%.
7. Serum direct bilirubin less than 1 mg/dl (unless due to Gilbert's syndrome or hemolysis).
8. SGPT equal or less than 4 x normal values.
9. Corrected DLCO equal or above 50% of expected.
10. Negative Beta HCG test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) and if fertile, males and females must agree to use contraceptives.
Exclusion Criteria:
1. Patients with low risk myelofibrosis.
2. Uncontrolled life-threatening infections.
3. HIV positive.
4. Patients with active viral hepatitis.
5. Prior treatment with Pacritinib.
6. Prior stem cell transplant.
7. QTc greater than 450 ms.
8. CYP3A4 strong or moderate inhibitors/inducers in the past 7 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02410551
Study Brief:
Protocol Section:
NCT02410551