NCT05123365 An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms
| NCT ID | NCT05123365 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Myeloproliferative Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2026-11-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age * Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria * Has not taken interferon-alpha or a JAK inhibitor (such as ruxolitinib or fedratinib) for treatment of MPN in the past 28 days before enrollment. * May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen. * Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment. * Baseline MPN-TSS score of ≥ 10 at the time of enrollment. * Peripheral blast count \<10% during Screening. * Free of other active or metastatic malignancies other than localized skin cancer. * Amenable to blood draws and symptom assessments. * Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearin