Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Angela G. Fleischman

Description

Summary

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

Details

This is a phase I/II open-label clinical trial determining the optimal biological dose (OBD) of N-acetylcysteine in subjects with myeloproliferative neoplasms. These are subjects who have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF).

Keywords

Myeloproliferative Neoplasm MPN Essential Thrombocythemia Polycythemia Vera Myelofibrosis Essential Thrombocytemia Neoplasms Primary Myelofibrosis Myeloproliferative Disorders Polycythemia Thrombocytosis Thrombocythemia, Essential Acetylcysteine N-monoacetylcystine N-Acetylcysteine

Eligibility

You can join if…

Open to people ages 18 years and up

  • ≥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 CAN'T join 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 × 109/L

  • Hgb < 10 g/dL
  • ANC < 0.75 × 109/L

  • Known history of allergic reaction to N-AC.

Location

  • Chao Family Comprehensive Cancer Center, University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Angela G. Fleischman
    Associate Professor, Medicine. Authored (or co-authored) 33 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05123365
Phase
Phase 1/2
Study Type
Interventional
Last Updated