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

Part of paid clinical trials in Irvine, California.

Sponsor
University of California, Irvine
Study ID
NCT05123365
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • N-Acetylcysteine — DRUG
    Given PO

Study Details

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

Key Dates

Start date
Jan 3, 2022
Status verified
Mar 2026
Primary completion
Nov 15, 2026
Completion
Nov 15, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1 (DL1)
    Patients take N-Acetylcysteince 600 mg orally twice daily. This is the starting dose level for the study.
  • Experimental: Dose Level 2 (DL2)
    Patients take N-Acetylcysteince 1200 mg orally twice daily. If DL1 is well tolerated, the next cohort will progress to this dose level.
  • Experimental: Dose Level 3 (DL3)
    Patients take N-Acetylcysteince 1800 mg orally twice daily. If DL2 is well tolerated, the next cohort will progress to this dose level.

Primary Outcome Measure

Optimal Biological Dose (OBD) of N-Acetylcysteine [ Time Frame: From the start date of treatment until 7 days after completion of treatment or removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, up to 8 weeks. ]

Central Contacts

  • Angela Fleischman, MD, PhD
    (714) 456-8000
    [email protected]
  • University of California Irvine Medical Center

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92617
Angela G Fleischman, MD PhD
[email protected]
(949) 999-2400
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868-

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By research site
University of California, Irvine· Irvine, CAChao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

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