NCT05123365 An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms
| NCT ID | NCT05123365 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of California, Irvine |
| Condition | Myeloproliferative Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2022-01-03 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase I/II study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).
Eligibility 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.
Contact & Investigator
Angela Fleischman, MD, PhD
PRINCIPAL INVESTIGATOR
Chao Family Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT05123365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05123365 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05123365 currently recruiting?
Yes, NCT05123365 is actively recruiting participants. Contact the research team at agf@hs.uci.edu for enrollment information.
Where is the NCT05123365 trial being conducted?
This trial is being conducted at Irvine, United States, Orange, United States.
Who is sponsoring the NCT05123365 clinical trial?
NCT05123365 is sponsored by University of California, Irvine. The principal investigator is Angela Fleischman, MD, PhD at Chao Family Comprehensive Cancer Center. The trial plans to enroll 27 participants.