An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

Recruiting now · Phase 1/Phase 2

Conditions studied: Myeloproliferative Neoplasm, MPN, Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis

In brief

This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).

Key facts

Study ID: NCT05123365
Run by: University of California, Irvine
People needed: 27
Starts: 2022-01-03
Expected to finish: 2026-11-15
Last updated by the study team: 2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥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 childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.

You may not qualify if…

Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3
Currently pregnant or planning on being pregnant within the study period.
Currently breastfeeding.
Known uncontrolled active viral or bacterial infection.
Significant impairment of major organ function defined as
Serum creatinine clearance less than 50 ml/min (calculated with Cockroft-Gault formula).
Bilirubin more than 1.5 mg/dl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.
Platelets < 100 × 10\^9/L
Hgb < 10 g/dL
ANC < 0.75 × 10\^9/L
Known history of allergic reaction to N-AC.

Where it is running

University of California, Irvine — Irvine, California, United States (enrolling)
Chao Family Comprehensive Cancer Center, University of California, Irvine — Orange, California, United States

Full record on ClinicalTrials.gov

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