[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kirsten Grønbæk\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100419455","phase-2-repurposing-metformin-as-a-leukemia-preventive-drug-in-ccus-and-lr-mds-100419455",false,"NCT04741945","Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS","STOP-LEUKEMIA: Repurposing Metformin As a Leukemia-preventive Drug in CCUS and LR-MDS","Patients are eligible to be included in WP1 if they meet all of the following criteria:\n\nInclusion criteria:\n\n* A diagnosis of:\n\n  * LR-MDS according to the revised international prognostic scoring system (IPSS-R), i.e., very low- or low-risk disease (IPSS-R score ≤3) in addition to a bone marrow blast percentage \\\u003C5 OR\n  * CCUS defined as the presence of somatic mutation(s) or cytogenetic abnormality not diagnostic of MDS or any other malignancy in the context of persistent cytopenia (\\>6 months) with other common causes of cytopenia ruled out in the setting of bone marrow morphology that is not diagnostic of MDS or any other malignancy, and hematolytic conditions have been ruled out. Peripheral blood cytopenia is defined as hemoglobin (hgb) \\\u003C11.3 g\u002FdL (7 mmol\u002FL) in women and hgb \\\u003C12.9 g\u002FdL (8 mmol\u002FL) in men, platelet count \\\u003C150 x 109\u002FL, or neutrophil count \\\u003C1.8 x 109\u002FL\n* Menopause, if being a female, defined as females \\>45 years of age who have experienced amenorrhea for minimum 12 months, without any other obvious pathological or physiological cause\n* ≥18 years of age\n* Written informed consent\n* Willingness to comply with mandatory aspects of the protocol\n* Ability to swallow pills\n\nExclusion criteria:\n\n* Any prior treatment with metformin\n* A diagnosis of diabetes mellitus\n* Therapeutic radiation, immunosuppressive therapy (with the exception of corticosteroids), or chemotherapy within the past year\n* Treatment with granulocyte colony-stimulating factor within the past 30 days\n* Prior therapy with hypomethylating agents (i.e., azacitidine, decitabine)\n* eGFR \\\u003C45 mL\u002Fmin\n* Performance status according to the Eastern Cooperative Oncology Group \\>2\n* Other active malignancy within the past five years\n* Uncontrolled comorbidity including impaired hepatic function (total serum bilirubin \\>1.5 × upper limit of the normal range (ULN), serum alanine transaminase \\>3 × ULN), chronic hepatitis with decompensated cirrhosis, disabling psychiatric disease, severe neurologic disease, uncontrolled metabolic disease, or severe cardiac disease (NYHA class 3-4)\n\nAn eGFR calculation performed up to one month prior to inclusion may be used to assess renal function. If such an assessment is not available, it is performed at screening.\n\nHealthy volunteers are eligible to be included in WP0 if they meet all of the following criteria:\n\nInclusion criteria:\n\n* Healthy individuals matched on age, sex, and BMI, if possible, to individual patient participants in WP1\n* Written informed consent\n* Willingness to comply with mandatory aspects of the protocol\n\nExclusion criteria:\n\n* Use of metformin within the past 3 years\n* A diagnosis of diabetes mellitus, rheumatological disorders, autoimmune diseases or other inflammatory disorders, celiac disease, inflammatory bowel disease, or other gastrointestinal disorders or symptoms\n* Treatment with immunosuppressive drugs (with the exception of corticosteroids) or chemotherapy within the past year or antibiotics within the past 6 months\n* Any contraindications to MRS",true,"ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single-arm pilot study of the feasibility and safety of metformin in patients with clonal cytopenia of undetermined significance (CCUS) or lower-risk myelodysplastic neoplasms (LR-MDS).",[27,28,29,30],"Preleukemia","Myelodysplastic Neoplasm","Cytopenia","Preleukemic Anemia",[32,28,33,34,35,36,37,38],"Metformin","Clonal Cytopenia of Undetermined Significance","Safety","Feasibility","Bone Marrow Adipose Tissue","Gut Microbiota","Intestinal Permeability","RECRUITING","2024-11-19",{"date":42,"type":43},"2024-11-22","ACTUAL",{"date":45,"type":43},"2021-12-13",{"date":47,"type":21},"2026-02",{"name":49,"class":50},"Kirsten Grønbæk","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100362479","phase-2-combining-active-and-passive-dna-hypomethylation-100362479","NCT03999723","Combining Active and Passive DNA Hypomethylation","Combining Active and Passive DNA Hypomethylation: A Randomized, Placebo-Controlled Phase II Study of the Efficacy and Safety of Oral Vitamin C in Combination With Azacitidine in Patients With Higher-Risk MDS, CMML-2 or Low-Blast Count AML","EVI-3","Inclusion Criteria:\n\n• Patients eligible for treatment with azacitidine with one of the following diagnoses according to World Health Organization 2016:\n\n* MDS Higher-risk MDS according to the IPSS-R, i.e., intermediate- to very high-risk (IPSS-R score \\> 3)\n* CMML CMML with 10-29 percent marrow blasts without myeloproliferative disorder\n* AML AML with 20-30 percent blasts (low-blast count AML)\n\nNote: Patients with therapy-related MDS are eligible if they have not received radiation or chemotherapy for six months.\n\nExclusion Criteria:\n\n* Patient eligible for allogeneic stem cell transplantation\n* Prior therapy with hypomethylating agents\n* Any matter constituting an exclusion criterion for treatment with azacitidine\n* Patient receiving other active cancer treatment, including investigational agents, with the exception of hydroxyurea for white blood cell (WBC) control, G-CSF, and low permanent doses of steroid (≤ 25 mg oral prednisolone per day) for inflammatory disorders\n* Therapeutic radiation or chemotherapy within the past 6 months\n* History of allergic reactions to ascorbic acid\n* History of kidney or urinary tract stones requiring intervention within the past year\n* Lack of ability to understand the information given, or lack of willingness to sign a written informed consent document\n* Unwillingness to comply with the protocol\n* Unwillingness to discontinue any and all use of vitamin C medication\u002Fsupplementation including multivitamin at least 3 days (but preferably longer) prior to inclusion and baseline sampling\n* Planned azacitidine treatment after allogeneic stem cell transplantation\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥3\n* Uncontrolled comorbidity including impaired hepatic function (total serum bilirubin \\>1.5 × upper limit of the normal range (ULN), serum alanine transaminase \\>3 × ULN, chronic hepatitis with decompensated cirrhosis), disabling psychiatric disease, severe neurologic disease, severe metabolic disease, or severe cardiac disease (NYHA class 3-4)",{"count":61,"type":21},196,[24],"This is a multicentre, randomized, parallel-group, placebo-controlled, double-blind phase 2 study of the efficacy and safety of oral vitamin C supplement in combination with azacitidine in patients with higher-risk MDS, CMML-2 or low-blast count AML. The primary purpose is to investigate if oral vitamin C supplementation to azacitidine, compared with azacitidine + placebo, can increase the effectiveness of epigenetic therapy in patients with higher-risk myeloid malignancies, who are not candidates for allogeneic hematopoietic stem cell transplantation.",[65,66,67],"Myelodysplastic Syndromes","Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia",[69,70,71,72,73],"Vitamin C","Ascorbic acid","Azacitidine","Hypomethylating agents","Randomized, Placebo-Controlled Trial","2024-04-16",{"date":76,"type":43},"2024-04-17",{"date":78,"type":43},"2019-09-11",{"date":80,"type":21},"2027-12",{"name":49,"class":50},10,""]