Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05123365

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

Led by University of California, Irvine · Updated on 2026-03-10

27

Participants Needed

2

Research Sites

253 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Diagnosed with essential thrombocythemia, polycythemia vera, or myelofibrosis based on 2016 WHO criteria
  • Have not used interferon-alpha or a JAK inhibitor for MPN treatment in the past 28 days
  • May continue current MPN treatments such as aspirin, hydroxyurea, or anagrelide
  • Have not taken N-acetylcysteine or related products in the past 28 days
  • Baseline MPN symptom score of 10 or higher at enrollment
  • Peripheral blast count less than 10% during screening
  • Free of other active or metastatic cancers except localized skin cancer
  • Able to have blood draws and symptom assessments
  • Agree to use effective contraception during the study and for 60 days after last dose if of childbearing potential
Not Eligible

You will not qualify if you...

  • ECOG score of 3 or higher
  • Currently pregnant or planning pregnancy during the study period
  • Currently breastfeeding
  • Known uncontrolled active viral or bacterial infection
  • Significant major organ impairment including:
    1. Serum creatinine clearance less than 50 ml/min
    2. Bilirubin over 1.5 mg/dl except Gilbert's disease; ALT or AST over twice normal limit or liver cirrhosis
    3. Platelet count below 100 x 10^9/L
    4. Hemoglobin below 10 g/dL
    5. Absolute neutrophil count below 0.75 x 10^9/L
  • Known allergy to N-acetylcysteine

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

University of California, Irvine

Irvine, California, United States, 92617

Actively Recruiting

2

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868

Active, Not Recruiting

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Research Team

A

Angela Fleischman, MD, PhD

CONTACT

U

University of California Irvine Medical Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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