[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clinical Hub for Interventional Research (CHOIR)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,77,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100617010","chapter-clonal-haematopoiesis-assessment-prevention-treatment-and-research-100617010",false,"NCT07313059","CHAPTER: Clonal Haematopoiesis Assessment: Prevention, Treatment and Research","Prospective Clinical Evaluation of Incidence, Outcomes and Individuals Experiences Following Diagnosis of Clonal Haematopoiesis in a Dedicated Research Clinic","CHAPTER","Inclusion Criteria:\n\n1. Aged 55 years and above\n2. Confirmed CH or possible CH, with possible CH defined by:\n\n   a. Persistent, non-severe cytopenia, characterised by one or more of the following, present on at least 2 occasions, at least 4 months apart (WHO criteria): i. Absolute neutrophil count (ANC) \\\u003C 1.8 x 109\u002FL ii. Haemoglobin (Hb) \\\u003C 120 g\u002FL in females, \\\u003C 130 g\u002FL in males iii. Platelet count \\\u003C 150 x 109\u002FL\n3. Provision of written informed consent prior to any study-related assessments or procedures being carried out.\n\nExclusion Criteria:\n\n1. Severe cytopenia as defined by one or more of the following:\n\n   1. ANC \\\u003C 0.5 x109\u002FL\n   2. Hb \\\u003C 80 g\u002FL\n   3. Platelet count \\\u003C 50 x 109\u002FL\n2. Multilineage cytopenias:\n\n   a. Marked trilineage cytopenia with all the following present: i. ANC \\\u003C 1.0 x 109\u002FL AND ii. Hb \\\u003C 110 g\u002FL AND iii. Platelet count \\\u003C 100 x 109\u002FL\n\n   b. Marked bilineage cytopenia, with two or more of the following present: i. ANC \\\u003C 1.0 x 109\u002FL ii. Hb \\\u003C 110 g\u002FL iii. Platelet count \\\u003C 100 x 109\u002FL\n\n   Note: People with possible CH, with the above characteristics will be excluded from referral to the CH clinic and will instead have urgent investigation as an inpatient or in the haematology clinic. However, if no definite cause for cytopenia is identified, including CH, then individuals may be referred for CH screening at the CH clinic the discretion of the study PI","ALL","55 Years",{"count":20,"type":21},100,"ESTIMATED","5 Years","OBSERVATIONAL","People identified to have CH or thought to have possible CH due to unexplained low blood cell counts, including low red blood cells, white blood cells, or platelets will be asked to take part in the study.\n\nIndividuals who are confirmed to have CH and provide informed consent to participate in the study will have monitoring of their CH, assessment of the risk of heart diseases, blood cancers and personalised support. The researchers will also measure people's understanding of CH and how they feel after learning about CH.\n\nResearchers will then record the relevant information from people with CH in a central database over time to track long-term health outcomes.\n\nThe information collected from the study will help create a blueprint for doctors to provide care for people with CH in the future, and guide further research into CH in Australia.\n\nParticipants will be asked to donate blood samples for the study for research purposes including CH monitoring and testing and also provide health information for the central database.",[26,27,28],"Clonal Hematopoiesis","CCUS Clonal Cytopenia of Undetermined Significance","Hematologic Disease and Disorders",[26,30,31],"CH","CCUS","RECRUITING","2026-05-11",{"date":35,"type":36},"2026-05-13","ACTUAL",{"date":38,"type":36},"2026-03-20",{"date":40,"type":21},"2033-11",{"name":42,"class":43},"Clinical Hub for Interventional Research (CHOIR)","OTHER_GOV",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100488161","phase-1-combined-evaluation-of-epigenetic-and-sensitising-therapy-in-aml-and-mds-100488161","NCT05636514","Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS","A Phase I Study of Oral Decitabine and Cedazuridine (ASTX727) In Combination With Defactinib (VS-6063) as Therapy of Myelodysplastic Syndromes and Low-blast Acute Myeloid Leukaemia","CELESTIAL-MDS","Inclusion Criteria:\n\nParticipants must meet all of the following criteria at the time of screening:\n\n1. Age ≥ 18 years\n2. Documented diagnosis of:\n\n   1. Myelodysplastic syndrome (MDS) classified as intermediate-2 or high risk according to the International Prognostic Scoring System (IPSS), or\n   2. Acute Myeloid Leukaemia (AML) with 20-30% marrow blasts and multilineage dysplasia, according to WHO classification, or\n   3. Chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder according to World Health Organisation (WHO) classification. This confirmation will be from either the Bone marrow aspirate (BMA) performed at screening or a standard of care BMA if performed up to 6 weeks before cycle 1 day 1.\n3. Performance status by Eastern Cooperative Oncology Group (ECOG) Criteria of 0 or 1\n4. Unsuitable for allogeneic stem cell transplantation\n5. For participants who were born female who are of childbearing potential (FCBP) the following criteria apply:\n\n   1. Agreement to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the study, and for 6 months following the last dose of study drug:\n\n      * Oral\u002Fintravaginal\u002Ftransdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n      * Oral\u002Finjectable\u002Fimplantable progestogen-only hormonal contraception associated with inhibition of ovulation\n      * Intrauterine device (IUD)\n      * Intrauterine hormone-releasing system (IUS)\n      * Bilateral tubal occlusion\n      * Vasectomised partner\n      * Sexual abstinence and\n   2. Confirmation of a negative serum pregnancy test at screening.\n6. Male participants with a partner who was born female and is of childbearing potential must agree to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the course of the study and for 6 months following the last dose of study drug, and refrain from donating sperm during the same period\n7. Provision of signed written informed consent document prior to any study related assessments or procedures being carried out.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria at the time of screening\u002Fenrolment (up to 28 days prior to Cycle 1 Day 1) will be ineligible for entry into the study:\n\n1. Acute myeloid leukemia (AML) with ≥ 30% blasts in bone marrow according to WHO classification.\n2. Prior allogeneic or autologous stem cell transplant.\n3. Prior receipt of \\>1 cycle of a hypomethylating agent.\n4. Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.\n5. Use of any of the following within 28 days prior to cycle 1 day 1:\n\n   1. thrombopoiesis-stimulating agents (\\[TSAs\\]; eg, Romiplostim, Eltrombopag, Interleukin-11)\n   2. ESAs (Erythropoiesis stimulating agent) and other RBC (Red blood cell) hematopoietic growth factors (eg, interleukin-3)\n   3. Any other investigational medicinal product from another clinical trial.\n6. Exposure to any medication, supplement, traditional\u002Fherbal medicine, or food with potential for drug-drug interactions with defactinib during the course of the study. This includes:\n\n   1. strong CYP3A4 inhibitors or inducers\n   2. strong CYP2C9 inhibitors or inducers\n   3. P-glycoprotein (P-gp) inhibitors or inducers\n7. Treatment with warfarin. Patients on warfarin can be converted to low molecular-weight heparin or direct oral anticoagulants (DOACs). Participants unwilling or unable to convert to an alternative are not eligible.\n8. Use of hydrea for more than 7 days prior to cycle 1 day 1. Use within that time period is permissible.\n9. Concurrent use of corticosteroids unless the participant is on a dose of ≤10mg prednisolone or equivalent for medical conditions other than MDS.\n10. Active inflammatory bowel disease, or any other gastrointestinal disorder or defect that would interfere with the ingestion, absorption, distribution, metabolism or excretion of the investigational products and\u002For predispose the participant to an increased risk of gastrointestinal toxicity.\n11. Prior history of malignancies, other than MDS unless the participant has been free of the disease for ≥ 12 months. However, participants with the following history\u002Fconcurrent conditions are allowed:\n\n    1. Basal or squamous cell carcinoma of the skin\n    2. Carcinoma in situ of the cervix\n    3. Carcinoma in situ of the breast\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system)\n12. Significant active cardiac disease within the previous 6 months, including:\n\n    1. New York Heart Association (NYHA) class III or IV congestive heart failure;\n    2. Unstable angina or angina requiring surgical or medical intervention; and\u002For\n    3. Myocardial infarction\n13. Baseline Qt interval greater than 440 milliseconds (males) or 450 milliseconds (females)\n14. Active systemic infection:\n\n    1. Infection with ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate anti- infectives\n    2. Active Hepatitis B (HBV) infection (defined as HBsAg positive, or HBcAb positive and measurable HBV DNA; participants who are HBcAb positive must have HBV DNA assayed during screening)\n    3. Participants with Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection will be considered individually by the coordinating principal investigator:\n\n       * Those with HIV will generally be eligible if receiving antiretroviral therapy, HIV viral load (VL) is suppressed \\\u003C50 copies\u002FmL , and CD4≥350 cells\u002Fmm3.\n       * Those with HCV will generally be eligible if there is no evidence of clinical hepatic dysfunction or other systemic manifestations of HCV disease and the hepatic parameters below are met. Consideration should be given to curative HCV therapy prior to enrollment in consultation with HCV clinician, if possible.\n15. Any of the following laboratory abnormalities:\n\n    1. Serum AST\u002FSGOT (Aspartate transaminase \u002F Serum glutamic oxaloacetic transaminase) or ALT\u002FSGPT (Alanine aminotransaminase \u002F Serum glutamic pyruvate transaminase) \\> 2.5 x ULN (upper limit of normal)\n    2. Serum total bilirubin \\> 1.5 x ULN. Patients with Gilbert syndrome may enroll if total bilirubin \\\u003C 51 umol\u002FL upon discussion with the coordinating investigator\n    3. Evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of \\> 2% with either a positive direct anti-globulin test (DAT) or over 50% of indirect bilirubin\n    4. Creatinine clearance \\\u003C50 ml\u002Fminute as calculated by the CockcroftGault formula or serum creatinine of ≥ 1.5 x ULN.\n    5. Absolute WBC (white blood cell count) ≥ 20 x 109\u002FL f ) Participants with isolated individual lab abnormalities considered to be disease related will be considered individually in consultation with the Coordinating Principal Investigator.\n16. Known or suspected hypersensitivity to study drugs or their constituents.\n17. Pregnant or breast-feeding.\n18. Any condition not already outlined above which, in the opinion of the clinical investigator, would place the participant at risk if they participated or would jeopardise adherence or follow up or confound the ability to interpret study data.","18 Years",{"count":55,"type":21},12,"INTERVENTIONAL",[58],"PHASE1","The goal of this project is to see if two new potential treatments (defactinib and the combination tablet of decitabine\u002Fcedazuridine) can safely be combined to improve outcomes in people with high-risk myelodysplastic syndrome (MDS), certain forms of Acute Myeloid Leukaemia (AML), and Chronic Myelomonocytic Leukaemia (CMML). Decitabine\u002Fcedazuridine is approved for use by the Australian Therapeutics Goods Administration (TGA) as treatment for MDS. Defactinib is an experimental treatment. This means it is not an approved treatment for MDS in Australia. So far it has been given to over 625 patients in studies across the world.\n\nAll study participants will receive active treatment, there is no placebo. Participants will take the decitabine\u002Fcedazuridine treatment once a day for 5 days in a row (day 1 to day 5) on its own for the first month (cycle). From month 2 participants will take the decitabine\u002Fcedazuridine treatment and will also take the defactinib treatment, both for 5 days in a row on days 1 to day 5 each month (cycle). Defactinib is taken twice a day.",[61,62,63],"Myelodysplastic Syndromes","Chronic Myelomonocytic Leukemia","Acute Myeloid Leukemia",[61,62,63,65,66,67],"MDS","AML","CMML","2026-03-16",{"date":70,"type":36},"2026-03-18",{"date":72,"type":36},"2022-12-14",{"date":74,"type":21},"2027-12-30",{"name":42,"class":43},5,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":56,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100626438","phase-2-modulation-of-stem-cell-differentiation-in-individuals-with-high-risk-clonal-haematopoiesis-100626438","NCT07435636","Modulation of Stem Cell Differentiation in Individuals With High Risk Clonal Haematopoiesis","A Multi-centre, Double-blind, Placebo-controlled Randomised Phase II Trial to Evaluate the Effect of Low Dose Decitabine and Tetrahydrouridine in Individuals With High-risk Clonal Haematopoiesis","MOSAIC","Inclusion Criteria:\n\n1. Age ≥ 60 and ≤ 85 years old\n2. Clonal Cytopenia of Uncertain Significance (CCUS), defined by all of the following:\n\n   a. Persistent cytopenia, present on at least two occasions, at least four months apart, with no other cause identified: i. Hemoglobin (Hb) \\\u003C 120 g\u002FL in people born female, and \\\u003C 130 g\u002FL in people born male ii. Platelet count \\\u003C 150 x 109\u002FL iii. Absolute Neutrophil Count (ANC) \\\u003C 1.8 x109\u002FL b. Clonal hematopoiesis (CH) driver mutation confirmed by custom gene panel mutation analysis c. absence of features diagnostic for defined myeloid neoplasm (MN) on bone marrow examination\n3. CH driver mutation variant allele fraction (VAF) of ≥ 10%\n4. For participants living with HIV:\n\n   1. Receiving and adherent to suppressive antiretroviral therapy for at least 12 months\n   2. CD4+T cell count ≥ 0.35 x 109\u002FL\n   3. HIV viral load \\\u003C 50 copies\u002FmL\n\n6\\. Performance status by Eastern Cooperative Oncology Group (ECOG) Criteria of 0 or 1 7. For participants who are of childbearing potential, or whose partners are of childbearing potential:\n\n1. Agreement to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the course of the trial, and for 6 months following the last dose of trial drug\n2. Refrain from donating eggs or sperm during the same period\n3. Confirmation of a negative serum pregnancy test at screening and at the beginning of each treatment cycle visit (for female participants of childbearing potential) 8. Provision of signed written informed consent document prior to any trial-related assessments or procedures being carried out\n\nExclusion Criteria:\n\n1. ANC \\\u003C 0.5 x109\u002FL\n2. Serum AST (Aspartate transaminase) or ALT (Alanine aminotransaminase) \\> 3 times of upper limit of normal\n3. Calculated or measured creatinine clearance ≤ 50 mL\u002Fmin\n4. Significant active cardiac disease within the previous 6 months, including:\n\n   1. New York Heart Association (NYHA) class III or IV congestive heart failure\n   2. Unstable angina or angina requiring surgical or medical intervention\n   3. Myocardial infarction\n   4. New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted\n5. Active systemic infections:\n\n   1. Infection with ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate anti-infectives\n   2. Active Hepatitis B infection (HBV) (defined as HBsAg positive, or HBcAb positive and measurable HBV DNA; participants who are HBcAb positive must have HBV DNA assayed during screening)\n   3. Active Hepatitis C Virus (HCV) will be ineligible if there is clinical hepatic dysfunction or other systemic manifestations of HCV disease, or if the hepatic eligibility parameters above are not met. Consideration should be given to curative HCV therapy prior to enrolment in consultation with HCV clinician\n6. Any history of hematological or solid malignancy in previous the 5 years unless the participant has been free of disease for ≥ 36 months. However, participants with the following history\u002Fconcurrent conditions are not excluded:\n\n   1. Basal or squamous cell carcinoma of the skin\n   2. Carcinoma in situ of the cervix\n   3. Carcinoma in situ of the breast\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system)\n7. Known hypersensitivity to trial drugs or their constituents\n8. Currently enrolled in the treatment phase of an interventional investigational trial.\n9. Pregnant or breast-feeding individuals\n10. Any condition not already outlined above which, in the opinion of the Principal Investigator, would place the participant at risk if they participated or would jeopardize adherence, follow up, or confound the ability to interpret trial data","60 Years","85 Years",{"count":88,"type":21},80,[90],"PHASE2","Clonal hematopoiesis (CH) is characterized by the overproduction of blood cells derived from a single hematopoietic stem and progenitor cell (HSPC) harboring certain somatic mutations. It is linked to serious outcomes, including cardiovascular disease, myeloid neoplasm (MN), and increased mortality.\n\nClonal Cytopenia of Uncertain Significance (CCUS) is a CH subtype characterized by associated persistent cytopenia. It affects approximately 10 % of people over 70 and is the most advanced precursor state with the highest risk of progressing to MN. There is an unmet need to determine whether modifying CH can prevent adverse outcomes. Current blood cancer therapies are too toxic for precursor conditions like CH.\n\nMOSAIC is a randomized double-blind placebo-controlled trial that will test a novel low-dose oral epigenetic therapy-decitabine with tetrahydrouridine (Dec+THU) in CCUS. It has shown targeted, non-cytotoxic reversal of common CH mutations in preclinical and early-phase studies.\n\nThe goal is to develop a safe and effective therapy in CCUS that restores normal blood cell production and prevents progression.",[93,27,26],"Clonal Cytopenia of Uncertain Significance",[83,30,95,31,96,97,98,93],"Modulation of stem cell differentiation","persistent cytopenia","clonal hematopoiesis","clonal haematopoiesis","NOT_YET_RECRUITING","2026-02-23",{"date":102,"type":36},"2026-02-27",{"date":104,"type":21},"2026-04-13",{"date":106,"type":21},"2030-10",{"name":42,"class":43},3,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":5},"100576259","evaluation-of-combined-sensitising-and-hypomethylating-therapy-outcomes-in-aml-pdx-100576259","NCT06782971","Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX","COSMOS-Avatar: Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX","COSMOS-Avatar","Inclusion Criteria:\n\n1. Age 18 years and above\n2. Patients with suspicion of AML requiring screening procedures\n3. Documented diagnosis of AML by WHO Classification and\u002For International Consensus Classification.\n\n   * Regardless of the number and type of prior lines of therapy or eligibility for allogeneic stem cell transplantation.\n   * All AML subtypes are eligible.\n   * Concurrent participation in clinical trials is allowed.\n4. Documented myeloblast percentage ≥20% in the bone marrow or peripheral blood within 12 weeks of C1D1 confirmed by bone marrow aspirate or peripheral blood smear.\n5. Planned to commence venetoclax and azacitidine therapy.\n6. Provision of written informed consent prior to any study-related assessments or procedures being carried out.\n\nExclusion Criteria:\n\n1\\. Presence of any condition that, by assessment of the Investigator, would compromise the safety of the patient if they participated, the quality of trial data, or their adherence to the study-specified procedures.",{"count":118,"type":21},25,"The goal of this observational study is to develop new ways to test new drug combinations to kill tumour cells, in patients with acute myeloid leukemia (AML). The main questions it aims to answer are:\n\n* Are there new ways to speed up discovery of better treatments for AML patients using AML cells from individual from patients in special mice that can accept human tissue?\n* Do these mice show treatment responses that are similar to the individual AML patient from whom cells were derived?\n\nParticipants with AML who are taking standard of care treatment of venetoclax and azacitidine will be asked to donate blood and bone marrow samples for this study.",[121],"AML - Acute Myeloid Leukemia",[66,63,123,124],"PDX","Patient-derived xenografts","2025-12-04",{"date":127,"type":36},"2025-12-08",{"date":129,"type":36},"2025-06-06",{"date":131,"type":21},"2030-03",{"name":42,"class":43},""]