[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preleukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preleukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100554600","phase-1-a-study-of-bh-30236-in-relapsed-refractory-acute-myelogenous-leukemia-and-higher-risk-myelodysplastic-syndrome-100554600",false,"NCT06501196","A Study of BH-30236 in Relapsed\u002F Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome","A Phase 1\u002F1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R\u002FR AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)","Inclusion criteria:\n\n* ≥18 years.\n* Diagnosis of relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.\n* Prior treatment history must include 1-5 prior lines of therapy.\n* ECOG performance status ≤2.\n* Adequate organ function evidenced by the following laboratory values:\n* Hepatic: Transaminase levels aspartate aminotransferase \\[AST\\]\u002F alanine transaminase \\[ALT\\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \\\u003C 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.\n* Renal: Measured or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n\nThe above are a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.\n* Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;\n* Active and uncontrolled infections.\n* Unresolved AEs greater than Grade from prior therapies.\n* History of other active malignancy (with certain exceptions)\n* Prior treatment with a CLK inhibitor.\n* Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.\n\nThe above is a summary, other exclusion criteria details may apply.","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Study BH-30236-01 is a first-in-human (FIH), Phase 1\u002F1b, open-label, dose escalation and expansion study in participants with relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR AML) or higher-risk myelodysplastic syndrome (HR-MDS).\n\nPhase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.\n\nPhase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.\n\nPhase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.",[26,27,28,29,30,31],"Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Preleukemia","Myelodysplastic Syndromes","Refractory Acute Myeloid Leukemia","RECRUITING","2025-09-19",{"date":35,"type":36},"2025-09-24","ACTUAL",{"date":38,"type":36},"2024-06-19",{"date":40,"type":20},"2027-06",{"name":42,"class":43},"BlossomHill Therapeutics","INDUSTRY",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100419455","phase-2-repurposing-metformin-as-a-leukemia-preventive-drug-in-ccus-and-lr-mds-100419455","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,{"count":54,"type":20},40,[56],"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).",[29,59,60,61],"Myelodysplastic Neoplasm","Cytopenia","Preleukemic Anemia",[63,59,64,65,66,67,68,69],"Metformin","Clonal Cytopenia of Undetermined Significance","Safety","Feasibility","Bone Marrow Adipose Tissue","Gut Microbiota","Intestinal Permeability","2024-11-19",{"date":72,"type":36},"2024-11-22",{"date":74,"type":36},"2021-12-13",{"date":76,"type":20},"2026-02",{"name":78,"class":79},"Kirsten Grønbæk","OTHER",1]