[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-marrow-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-marrow-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,80,109],{"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":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100622725","phase-1-pacritinib-with-aza-for-upfront-myelodysplastic-syndrome-100622725",false,"NCT07387354","Pacritinib With Aza for Upfront Myelodysplastic Syndrome","A Phase 1\u002F2 Study of Pacritinib in Combination With Azacitidine for the Treatment of IPSS-M Moderate Low to Very High Risk Myelodysplastic Syndrome","MDS","Inclusion Criteria:\n\n* Individuals must meet all of the following inclusion criteria to be eligible to participate in the study:\n\n  1. Patients must have histologic evidence of intermediate to high-risk myelodysplastic syndrome defined as having an IPSS-M score of moderate low, moderate high, high or very high risk. This will be assessed based on evaluations performed prior to screening for trial. Of note, the most recent evaluation pre-trial may be used which does not have to necessarily be at diagnosis.\n  2. Subjects must have recovered from the toxic effects of any prior chemotherapy to ≤ Grade 1 (except alopecia).\n  3. Required screening visit laboratory values: CrCL ≥45; total bilirubin \\\u003C2xULN except for patients with known Gilbert's disease; SGPT (ALT) ≤2xULN, PTT ≤1.5xULN.\n  4. Negative pregnancy test for women with child-bearing potential at screening visit.\n  5. Initial screening baseline QTc ≤480ms.\n  6. Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.\n  7. Patients must have an absolute neutrophil count of ≥750 to enroll in study, this must be achieved without the addition of growth factor medication.\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Any prior exposure to a hypomethylating agent (azacitidine or decitabine)\n  2. Any prior exposure to JAK2 inhibitor therapy (ie ruxolitinib or prior pacritinib therapy)\n  3. Any exposure within the past seven days of initiation of study treatment to a strong CYP3A inhibitor\u002Finducer.\n  4. Subjects must not be receiving any chemotherapy agents (except hydroxyurea) within the past thirty days.\n  5. Subjects must not be receiving growth factors (erythropoietin mimetics, granulocyte stimulating factor mimetics, thrombopoietin mimetics) for two weeks prior to enrollment bone marrow. Subjects may not receive growth factors for the duration of this study.\n  6. Subjects with a \"currently active\" second malignancy, other than curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pT2 with Gleason Score ≤ 6 and postoperative PSA \\\u003C0.5 ng\u002FmL), or other adequately treated carcinoma-in-situ are eligible. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 1 year.\n  7. Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure (NYHA class 2), myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.\n  8. Bleeding event grade \\>=2 (CTCAE 5.0) within prior three months unless provoked (e.g., by surgery or trauma)\n  9. Use of anticoagulant or antiplatelet agents within fourteen days prior to day one with the exception of low dose aspirin (81mg daily).\n  10. Subjects with other severe concurrent disease which in the judgment of the investigator would make the patient inappropriate for entry into this study are ineligible.\n  11. Active or uncontrolled diarrhea or constipation.\n  12. Subjects must not have evidence of active disease in the CNS.\n  13. Subjects must not have received any investigational agents within fourteen days or five half-lives (whichever is longer) of study entry.\n  14. Subjects must not be pregnant or breastfeeding. Pregnancy tests must be obtained for all females of child-bearing potential. Pregnant or lactating patients are ineligible for this study due to the unknown human fetal or teratogenic toxicities of pacritinib. Males or women of childbearing potential may not participate unless they have agreed to use a highly effective contraceptive method (defined in section 10.4.4).\n  15. Subjects who have uncontrolled infection are not eligible. Patients must have any active infections under control. Fungal disease must be stable for at least two weeks before study entry.\n  16. Subjects with bacteremia must have documented negative blood cultures prior to study entry.\n  17. Subjects who are currently candidates for allogeneic transplantation, have a suitable donor, and are willing to undergo transplantation prior to study start.\n  18. Subjects who cannot hold a medication, over the counter, or supplemental product that in the investigator's opinion may put the patient at increased harm.","ALL","18 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study will be conducted as a phase 1\u002F2 study of safety and preliminary efficacy of pacritinib in combination with azacitidine for IPSS-M moderate low to very high risk MDS. Phase one will be a 3 + 3 design to assess the dose for the phase two portion. The phase two portion will employ a simon min-max two-stage design whereby fifteen patients will be enrolled in the first stage then ten more if at least two patients in stage one have a response. The dosing of pacritinib for the phase two study will be based on the phase one findings. Standard dosing of azacitidine will be used. A correlative study will be conducted in conjunction with the trial where the investigators will measure whole blood collected pre-treatment and at four days post-treatment to measure intracellular flow and phosflow to detect JAK\u002FSTAT, NF-κβ, and AKT\u002FmTOR signaling in patient samples and how treatment affects these pathways.",[28,15,29,30,31,32],"Myelodysplastic Syndromes","Myelodysplastic Syndrome, Unclassifiable","Hematologic Diseases","Bone Marrow Disease","Myeloproliferative Neoplasm",[34,35,36,37,38,39,40],"Pacritinib","Azacitidine","IPSS-M","JAK\u002FSTAT","JAK\u002FIRAK1","NF-κβ","Myelodysplastic Syndrome","NOT_YET_RECRUITING","2026-06-08",{"date":44,"type":45},"2026-06-10","ACTUAL",{"date":47,"type":21},"2026-07",{"date":49,"type":21},"2027-01",{"name":51,"class":52},"Thomas Jefferson University","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100570122","role-of-diffusion-mri-in-differentiation-of-various-bone-marrow-lesions-100570122","NCT06703138","Role of Diffusion MRI in Differentiation of Various Bone Marrow Lesions","Role of MRI Diffusion in Differentiation Between Various Vertebral Bone Marrow Pathological Lesions. .","Inclusion Criteria:\n\n* All adult patients with vertebral lesions Clinically suspected or diagnosed by other modalities as X-ray or CT were included in the study.\n\nExclusion Criteria:\n\n* Patients with metallic prosthesis which are not MRI compatible .\n* patients with previous Vertebral surgery.\n* patients with Vertebral Congenital anomalies\n* Patients refused the examination.\n* Patients who suffer from claustrophobia","20 Years","60 Years",{"count":63,"type":21},70,"OBSERVATIONAL","Bone marrow lesions are common, and imaging findings are associated with various aetiologies, as compared to conventional radiography and computed tomography (CT), MRI is a better non-invasive imaging modality to evaluate vertebral bone marrow, due to better soft-tissue contrast, so the aim of our study is the use of MRI diffusion in differentiating various vertebral bone marrow pathological lesions.",[67,31],"Diffusion MRI",[69,70],"MRI","Bone marrow pathologies","2024-11-26",{"date":73,"type":45},"2024-11-29",{"date":75,"type":21},"2024-12-15",{"date":77,"type":21},"2026-01",{"name":79,"class":52},"Assiut University",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100561807","phase-2-a-study-of-hs-20106-to-treat-anemia-due-to-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-100561807","NCT06594965","A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes","Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia","Inclusion Criteria:\n\n1. Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.\n2. \\\u003C 5% blasts in bone marrow and \\\u003C 1% blasts in peripheral blood.\n3. Each cohort is defined as:\n\n   Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g\u002FL.\n\n   Cohort 2： In LTB participants, having received an average of \\\u003C 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n\n   In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.\n5. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.\n\nExclusion Criteria:\n\n1. Chromosome 5q deletion, del (5q).\n2. Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.\n3. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases).\n4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.\n5. Treatment within 4 weeks prior to C1D1 with:\n\n1\\) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use \\\u003C or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.\n\n9\\. Peripheral blood white blood cell count \\>13.0 x 10\\*9\u002FL. 10. Neutrophil count \\\u003C 1.0 x 10\\*9\u002FL. 11. Platelet count \\> 450 x 10\\*9\u002FL or \\\u003C 30 x 10\\*9\u002FL. 12. Transferrin saturation \\\u003C 15%. 13. Ferritin \\\u003C 15 μg\u002FL. 14. Folate \\\u003C 4.5 nmol\u002FL (\\\u003C 2.0 ng\u002FmL). 15. Vitamin B12 \\\u003C 148 pmol\u002FL (\\\u003C 200 pg\u002FmL). 16. Estimated glomerular filtration rate (GFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\].\n\n17\\. Pregnant or lactating females",{"count":88,"type":21},176,[25],"The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.",[28,92,15,31],"Anemia",[15,94,95,96,97],"HS-20106","KER-050","fusion protein","TGF-β","2024-09-14",{"date":100,"type":45},"2024-09-19",{"date":102,"type":21},"2024-10-30",{"date":104,"type":21},"2026-10-30",{"name":106,"class":107},"Hansoh BioMedical R&D Company","INDUSTRY",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100495566","osteomics-identifying-regulators-of-bone-homeostasis-100495566","NCT05732870","OSTEOMICS: Identifying Regulators of Bone Homeostasis","OSTEOMICS","Inclusion Criteria:\n\n1. Patients with osteoarthritis undergoing total joint arthroplasty, osteotomy or arthrodesis of any joint (including hip, knee, shoulder, wrist, elbow, ankle).\n2. Patient with fractured neck of femurs undergoing hemiarthroplasty or total hip arthroplasty, or other internal fixation procedure.\n3. Patients undergoing acute low-velocity or fragility fracture fixation surgery.\n4. Patients aged between 18-110 years old with capacity to consent.\n\nSince deteriorating bone health including diseases like osteoporosis are primarily conditions of older age there is no practical upper age-limit. However, study involvement is limited by suitability for surgery which encompasses multiple factors considered on an individual case basis including age, frailty, comorbidities, baseline mobility, renal function and ability to consent (for instance due to dementia or delirium).\n\nWe note that our inclusion criteria is purposefully broad as we aim to deduce trends across a wide range of conditions and backgrounds.\n\nExclusion Criteria:\n\n1. Patients unable to provide informed consent.\n2. Patients with suspected\u002Festablished underlying malignancy.\n3. Patients with suspected\u002Festablished osteomyelitis.\n4. Patients with suspected\u002Festablished bloodborne disease\n5. Patients who are currently a subject of a clinical trial involving an investigational medicinal product.","110 Years",{"count":118,"type":21},2000,"Diseases of bone associated with ageing, including osteoporosis (OP) and osteoarthritis (OA), reduce bone mass, bone strength and joint integrity. Current non-surgical approaches are limited to pharmaceutical agents that are not disease modifying and have poor patient tolerability due to side effect profiles. Developing a fundamental understanding of cellular bone homeostasis, including how key cell types affect tissue health, and offering novel therapeutic targets for prevention of bone disease is therefore essential. This is the focus of OSTEOMICS.\n\nA number of factors have been linked to increased risk of bone disease, including genetic predisposition, diet, smoking, ageing, autoimmune disorders and endocrine disorders. In our study, we will recruit patients undergoing elective and non-elective orthopaedic surgery and obtain surgical bone waste for analysis. This will capture a cohort of patients with bone disorders like OP and OA, in addition to patients without overt clinical bone disease. We will study the relationship between the molecular biology of bone cells, bone structure, genetics (DNA) and environmental factors with the aim of identifying and validating novel therapeutic targets.\n\nWe will leverage modern single cell technologies to understand the diversity of cell types found in bone. These technologies have now led to the characterisation of virtually every tissue in the body, however bone and bone-adjacent tissues are massively underrepresented due to the anatomical location and underlying technical challenges. Early protocols to demineralise bone and perform single cell profiling have now been developed. We will systematically scale up these efforts to observe how genetic variation at the population level leads to alterations in bone structure and quality.\n\nOver the next 10 years, we will generate data to comprehensively characterise bone across health and disease, use machine learning to drive analysis, and experimentally validate hypotheses - which will ultimately contribute to developing the next generation of therapeutic agents.",[121,122,123,124,31],"Osteoporosis","Osteoarthritis","Bone Diseases","Bone Fracture","RECRUITING","2024-02-20",{"date":128,"type":45},"2024-02-23",{"date":130,"type":45},"2023-01-12",{"date":132,"type":21},"2032-12",{"name":134,"class":107},"Relation Therapeutics",8]