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An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05123365•University of California, Irvine

View on ClinicalTrials.gov

Summary

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

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (2)

University of California, Irvine

Irvine, California, United States

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Key Dates

Start Date

January 3, 2022

Primary Completion Date

November 15, 2026

Completion Date

November 15, 2026

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Myeloproliferative NeoplasmMPNEssential ThrombocythemiaPolycythemia VeraMyelofibrosis

Interventions

N-Acetylcysteine

DRUG

Contacts

Angela Fleischman, MD, PhD

CONTACT

(714) 456-8000 agf@hs.uci.edu

University of California Irvine Medical Center

CONTACT

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

NCT06456346

Essential Thrombocythemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

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Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)