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Antioxidant

N-Acetylcysteine for Myeloproliferative Disorders

Verified Trial
Phase 1 & 2
Waitlist Available
Led By Angela Fleischman, MD, PhD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria
Must not have
Are you currently taking interferon or a Jak inhibitor?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days prior to beginning treatment until end of treatment, average of 9 weeks.
Awards & highlights

Study Summary

This trial is testing a possible new treatment for blood cancer using a drug called N-acetylcysteine. They are trying to find the best dose of the drug to give to patients.

Who is the study for?
Adults diagnosed with essential thrombocythemia, polycythemia vera, or myelofibrosis can join this trial. They must be on stable MPN treatment and not have used interferon-alpha, JAK inhibitors, or N-Acetylcysteine recently. Participants need a certain symptom score and agree to use contraception. Those with severe allergies to N-AC, poor organ function, low blood counts, active infections or pregnancy are excluded.Check my eligibility
What is being tested?
The study is testing the best dose of a drug called N-Acetylcysteine for patients with myeloproliferative neoplasms (MPNs). It's in early stages (phase I/II) to see how much should be given safely while participants continue their usual treatments for MPNs.See study design
What are the potential side effects?
Potential side effects of N-Acetylcysteine may include allergic reactions for those sensitive to it. Since this is a dose-finding study, other specific side effects will be monitored as different doses are tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with ET, PV, or MF according to the latest criteria.
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I have been diagnosed with ET, PV, or MF according to the latest criteria.
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I have no active cancers except for skin cancer that hasn't spread.
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I am willing to have my blood drawn and my symptoms checked regularly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently taking interferon or a Jak inhibitor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days prior to beginning treatment until end of treatment, average of 9 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days prior to beginning treatment until end of treatment, average of 9 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Optimal Biological Dose (OBD) of N-Acetylcysteine
Proportion of subjects who achieve 30% reduction of MPN-SAF Total symptom score (MPN-TSS)

Side effects data

From 2015 Phase 3 trial • 302 Patients • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Alcohol abuse
1%
Road traffic accident
1%
Cellulitis
1%
Arthropod bite
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM

Trial Design

3Treatment groups
Experimental Treatment
Group I: Dose Level 3 (DL3)Experimental Treatment1 Intervention
Patients take N-Acetylcysteince 1800 mg orally twice daily. If DL2 is well tolerated, the next cohort will progress to this dose level.
Group II: Dose Level 2 (DL2)Experimental Treatment1 Intervention
Patients take N-Acetylcysteince 1200 mg orally twice daily. If DL1 is well tolerated, the next cohort will progress to this dose level.
Group III: Dose Level 1 (DL1)Experimental Treatment1 Intervention
Patients take N-Acetylcysteince 600 mg orally twice daily. This is the starting dose level for the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
536 Previous Clinical Trials
1,921,573 Total Patients Enrolled
Angela Fleischman, MD, PhDPrincipal InvestigatorChao Family Comprehensive Cancer Center

Media Library

Myeloproliferative Neoplasms Research Study Groups: Dose Level 1 (DL1), Dose Level 2 (DL2), Dose Level 3 (DL3)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathologies is N-Acetylcysteine typically employed to ameliorate?

"N-Acetylcysteine is frequently utilized to treat corneal ulceration, acute rhinitis, acetaminophen poisoning and other ocular conditions."

Answered by AI

To what extent has the capacity of this study been reached?

"Unfortunately, this research is not currently accepting participants. It was first published on March 1st of 2022 and last modified 20 days later. If you are interested in additional studies, there are 2540 trials for polycythemia vera that still have openings as well as 38 clinical investigations into N-Acetylcysteine recruiting volunteers."

Answered by AI

Are there any prior studies that have employed N-Acetylcysteine as a therapeutic agent?

"Currently, there are 38 investigations into N-Acetylcysteine underway with 7 initiatives in the advanced Phase 3. 44 distinct medical sites have research programs for this compound, several of which are situated in New york City."

Answered by AI

Are recruitment efforts still underway for this research endeavor?

"According to data hosted on clinicaltrials.gov, the trial is not currently accruing patients as recruitment had ceased since January 20th 2022. However, there are 2578 other studies where patient enrolment is taking place at present."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Chao Family Comprehensive Cancer Center, University of California, Irvine
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Jul 2024