An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine
About this trial
This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).
Eligibility criteria
Qualifiers
≥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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- N-Acetylcysteine
Treatment groups
27 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov