RECRUITING

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

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Conditions

Myeloproliferative NeoplasmMPNEssential ThrombocythemiaPolycythemia VeraMyelofibrosisEssential Thrombocytemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-01-03
Study Completion:2026-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05123365

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria
  3. * 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.
  4. * May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen.
  5. * Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment.
  6. * Baseline MPN-TSS score of ≥ 10 at the time of enrollment.
  7. * Peripheral blast count \<10% during Screening.
  8. * Free of other active or metastatic malignancies other than localized skin cancer.
  9. * Amenable to blood draws and symptom assessments.
  10. * 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.
  1. * Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3
  2. * Currently pregnant or planning on being pregnant within the study period.
  3. * Currently breastfeeding.
  4. * Known uncontrolled active viral or bacterial infection.
  5. * Significant impairment of major organ function defined as
  6. 1. Serum creatinine clearance less than 50 ml/min (calculated with Cockroft-Gault formula).
  7. 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.
  8. 3. Platelets \< 100 × 10\^9/L
  9. 4. Hgb \< 10 g/dL
  10. 5. ANC \< 0.75 × 10\^9/L
  11. * Known history of allergic reaction to N-AC.

Contacts and Locations

Study Contact

Angela Fleischman, MD, PhD
CONTACT
(714) 456-8000
agf@hs.uci.edu
University of California Irvine Medical Center
CONTACT

Principal Investigator

Angela Fleischman, MD, PhD
PRINCIPAL_INVESTIGATOR
Chao Family Comprehensive Cancer Center

Study Locations (Sites)

University of California, Irvine
Irvine, California, 92617
United States
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: University of California, Irvine

  • Angela Fleischman, MD, PhD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-03
Study Completion Date2026-11-15

Study Record Updates

Study Start Date2022-01-03
Study Completion Date2026-11-15

Terms related to this study

Keywords Provided by Researchers

  • MPN
  • Myeloproliferative Neoplasm
  • Essential Thrombocytemia
  • Polycythemia Vera
  • Myelofibrosis

Additional Relevant MeSH Terms

  • Myeloproliferative Neoplasm
  • MPN
  • Essential Thrombocythemia
  • Polycythemia Vera
  • Myelofibrosis