Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05123365 | RECRUITING | Myeloproliferative Neoplasm

An Optimal Dose Finding Study of N-Acetylcysteine in Patients with Myeloproliferative Neoplasms
Sponsor:

University of California, Irvine

Information provided by (Responsible Party):

Angela G. Fleischman

Brief Summary:

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

Condition or disease

Myeloproliferative Neoplasm

MPN

Essential Thrombocythemia

Polycythemia Vera

Myelofibrosis

Intervention/treatment

N-Acetylcysteine

Phase

PHASE1

PHASE2

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 27 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : An Optimal Dose Finding Study of N-Acetylcysteine in Patients with Myeloproliferative Neoplasms
Actual Study Start Date : 2022-01-03
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2026-11-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
An Optimal Dose Finding Study of N-Acetylcysteine in Patients with Myeloproliferative Neoplasms

Location Details

NCT05123365

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California, Irvine

Irvine, California, United States, 92617

ACTIVE NOT RECRUITING

United States, California

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868