An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neop
This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).
| Condition(s) | Myeloproliferative Neoplasm, MPN, Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN). |
| Who can participate | 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 t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of California, Irvine |
| Locations | Irvine, California, United States; Orange, California, United States |
| Start date | 2022-01-03 |
| NCT ID | NCT05123365 |
| Official listing | https://clinicaltrials.gov/study/NCT05123365 |