Finding the best dose of N-Acetylcysteine for patients with blood disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is an open-label phase I/II study aimed at determining the optimal biological dose of N-acetylcysteine (N-AC) for patients diagnosed with myeloproliferative neoplasms, including essential thrombocythemia, polycythemia vera, and myelofibrosis. Participants will be evaluated based on their response to N-AC while continuing their current MPN treatments. The study will assess the safety and efficacy of N-AC in improving symptoms associated with these blood disorders.

Why it matters

Who can join: the full rules

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 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.

Exclusion Criteria:

* 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

  1. Serum creatinine clearance less than 50 ml/min (calculated with Cockroft-Gault formula).
  2. 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.
  3. Platelets \< 100 × 10\^9/L
  4. Hgb \< 10 g/dL
  5. ANC \< 0.75 × 10\^9/L
* Known history of allergic reaction to N-AC.

Where it's running

• University of California, Irvine
  Irvine, California, United States Recruiting
• Chao Family Comprehensive Cancer Center, University of California, Irvine
  Orange, California, United States Active not recruiting

Study contacts

• Principal investigator: Angela Fleischman, MD, PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Angela Fleischman, MD, PhD
• Email: agf@hs.uci.edu
• Phone: (714) 456-8000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of Asian patients with myeloproliferative neoplasms

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.