[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05123365":3,"trial-entities:NCT05123365":116,"trial-summary:NCT05123365":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":14,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":77,"locations":80,"central_contacts":103,"overall_officials":110,"references":114,"see_also_links":115},"NCT05123365","20216930","An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms","RECRUITING","2026-11-15","2026-03","2026-03-10","2022-01-03","University of California, Irvine","OTHER",null,"This is a phase I\u002FII study evaluating the optimal dose of N-acetylcysteine (N-AC) in patients with myeloproliferative neoplasms (MPN).","This is a phase I\u002FII 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).",[18,19,20,21,22],"Myeloproliferative Neoplasm","MPN","Essential Thrombocythemia","Polycythemia Vera","Myelofibrosis",[19,18,24,21,22],"Essential Thrombocytemia","INTERVENTIONAL","TREATMENT",[28,29],"PHASE1","PHASE2",{"count":31,"type":32},27,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":42},"DRUG","N-Acetylcysteine","Given PO",[39,40,41],"Dose Level 1 (DL1)","Dose Level 2 (DL2)","Dose Level 3 (DL3)",[43],"N-AC",[45,49],{"measure":46,"description":47,"timeFrame":48},"Optimal Biological Dose (OBD) of N-Acetylcysteine","Determination of the optimal biological dose (OBD) will be utilized to evaluate the safety and tolerability of N-AC as a treatment for patients with MPN. Optimal biological dose is defined as the therapeutic dose that possesses the highest efficacy probability while inducing acceptable toxicity","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.",{"measure":50,"description":51,"timeFrame":52},"Proportion of subjects who achieve 30% reduction of MPN-SAF Total symptom score (MPN-TSS)","MPN-SAF Total symptom score (MPN-TSS) is a validated tool to objectively measure the burden of symptoms associated with MPN. Baseline TSS will be defined as the average of the daily TSS of 7 consecutive days immediately prior to beginning N-AC. The end of study MPN-TSS will be defined as the average of the daily TSS of 7 consecutive days during week 8.","7 days prior to beginning treatment until end of treatment, average of 9 weeks.",[],"ALL","18 Years",false,{"inclusion":58,"exclusion":69,"raw_text":76},[59,60,61,62,63,64,65,66,67,68],"≥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 \\\u003C10% 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.",[70,71,72,73,74,75],"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","Known history of allergic reaction to N-AC.","Inclusion Criteria:\n\n* ≥18 years of age\n* Have a diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or myelofibrosis (MF) according to the 2016 WHO criteria\n* 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.\n* May continue on current MPN treatment, including aspirin, hydroxyurea, or anagrelide. Therapeutic phlebotomies should continue per the patient's usual regimen.\n* Has not taken N-Acetylcysteine (N-AC) or preparations containing N-AC in the past 28 days before enrollment.\n* Baseline MPN-TSS score of ≥ 10 at the time of enrollment.\n* Peripheral blast count \\\u003C10% during Screening.\n* Free of other active or metastatic malignancies other than localized skin cancer.\n* Amenable to blood draws and symptom assessments.\n* 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.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3\n* Currently pregnant or planning on being pregnant within the study period.\n* Currently breastfeeding.\n* Known uncontrolled active viral or bacterial infection.\n* Significant impairment of major organ function defined as\n\n  1. Serum creatinine clearance less than 50 ml\u002Fmin (calculated with Cockroft-Gault formula).\n  2. Bilirubin more than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.\n  3. Platelets \\\u003C 100 × 10\\^9\u002FL\n  4. Hgb \\\u003C 10 g\u002FdL\n  5. ANC \\\u003C 0.75 × 10\\^9\u002FL\n* Known history of allergic reaction to N-AC.",[78,79],"ADULT","OLDER_ADULT",[81,95],{"facility":12,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Irvine","California","92617","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Angela G Fleischman, MD PhD","CONTACT","(949) 999-2400","agf@uci.edu",{"lat":93,"lon":94},33.66946,-117.82311,{"facility":96,"status":97,"city":98,"state":83,"zip":99,"country":85,"geoPoint":100},"Chao Family Comprehensive Cancer Center, University of California, Irvine","ACTIVE_NOT_RECRUITING","Orange","92868",{"lat":101,"lon":102},33.78779,-117.85311,[104,108],{"name":105,"role":89,"phone":106,"email":107},"Angela Fleischman, MD, PhD","(714) 456-8000","agf@hs.uci.edu",{"name":109,"role":89},"University of California Irvine Medical Center",[111],{"name":105,"affiliation":112,"role":113},"Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":117,"biomarkers":118},[20,22,21],[],{"nct_id":4,"found":120,"summary":121,"prompt_version":131},true,{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is a Phase I\u002FII open-label study, meaning both you and your doctors will know what treatment you are receiving. It aims to find the best dose of N-Acetylcysteine and plans to enroll 27 participants.","completed","Optimal Dose Finding Study of N-Acetylcysteine for Myeloproliferative Neoplasms","This study is looking for the best dose of N-Acetylcysteine for people with myeloproliferative neoplasms (MPN). MPN is a group of blood cancers that includes essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF). The study will test different doses of N-Acetylcysteine, given by mouth, to see which dose works best. Researchers will measure the optimal biological dose (OBD) of N-Acetylcysteine and see if symptoms improve, specifically if 30% of participants have a reduction in their MPN-SAF Total Symptom Score. You may be able to join if you are at least 18 years old and have been diagnosed with ET, PV, or MF. The study is currently unclear about its recruitment status and plans to enroll 27 participants.","The study will track the optimal biological dose until 7 days after treatment completion or removal. Symptom reduction will be measured until the end of treatment.",118,"Treatment will last up to 8 weeks, or longer if you continue to benefit. Symptom scores will be measured for an average of 9 weeks.","Not stated in the trial record.",[36],"v2"]