[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"poor-graft-function\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:poor-graft-function":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,66,90,117],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100559818","cd34-selected-stem-cell-for-poor-graft-function-or-graft-failure-100559818",false,"NCT06569082","CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure","CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.\n* Documented evidence of graft dysfunction or failure (a-c):\n\n  1. Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism \\> 50% by day 45 not due to the underlying malignancy;\n  2. Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \\\u003C 8 g\u002FdL, ANC \\\u003C 0.5x109\u002FL, and platelets \\\u003C 20x109\u002FL. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;\n  3. Secondary graft failure is defined as poor graft function associated with donor chimerism \\\u003C 5% after initial engraftment\n* Transplanted donor availability\n* Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.\n\nExclusion Criteria:\n\n* Graft failure due to disease relapse or evidence of disease relapse or progression\n* Donor unavailable or unable to collect peripheral HPC by apheresis\n* Responsive to conventional measures (such as, hematopoietic growth factor)\n* Allergic reaction to murine proteins or iron dextran\n* Women of childbearing potential with positive serum HCG","ALL","18 Years",{"count":19,"type":20},21,"ESTIMATED","INTERVENTIONAL",[23],"NA","The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.",[26,27],"Graft Failure","Poor Graft Function","RECRUITING","2025-09-23",{"date":31,"type":32},"2025-09-29","ACTUAL",{"date":34,"type":32},"2024-10-31",{"date":36,"type":20},"2035-08",{"name":38,"class":39},"NYU Langone Health","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":40},"100577006","phase-1-the-safety-and-efficacy-of-umbilical-cord-blood-mononuclear-cells-in-patients-with-secondary-poor-graft-function-after-hematopoietic-stem-cell-transplantation-100577006","NCT06792682","The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation","Clinical Study to Explore the Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Age≥18 years old; gender is not limited.\n2. Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10\\^9\u002FL for 3 consecutive days without G-CSF application, PLT ≥ 20×10\\^9\u002FL for 7 consecutive days without platelet infusion, Hb ≥ 80g\u002FL for 2 consecutive weeks without red blood cell infusion) again developed two or three line cytopenia lasting more than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission of primary disease, complete donor chimeric cells, and no severe graft-versus-host disease (GVHD) or disease recurrence.\n3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.\n4. Subjects sign informed consent.\n\nExclusion Criteria:\n\n1. Serious infection not controlled.\n2. Active bleeding.\n3. Patients with cardiac insufficiency (ejection fraction\\\u003C50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.\n4. Patients with hepatic and renal insufficiency (total bilirubin\\>35µmol\u002FL, ALT and AST\\>2 times of the upper limit of normal; serum creatinine\\>130µmol\u002FL).\n5. Pregnant or lactating women.\n6. Concurrent malignant tumors of other organs.\n7. Failure to understand or follow the research protocol.\n8. Patients participating in other clinical investigations.\n9. Other conditions that the investigators consider inappropriate to participate in the study.",{"count":49,"type":20},15,[51],"PHASE1","This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.",[27],[55,56],"Secondary poor graft function","Umbilical cord blood mononuclear cells","2025-03-11",{"date":59,"type":32},"2025-03-13",{"date":61,"type":32},"2025-02-14",{"date":63,"type":20},"2028-02",{"name":65,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":40},"100562761","phase-1-rescuing-bone-marrow-function-in-patients-with-aplastic-anaemia-and-bone-marrow-failure-post-allogeneic-transplantation-2-100562761","NCT06607367","REscuing Bone Marrow Function in Patients with AplaStic AnaEmia and Bone Marrow FaiLure Post AllogEneiC Transplantation 2","RESELECT2","Inclusion Criteria:\n\nPatient must meet ALL of the following:\n\n1. Poor Graft function OR Relapsed\u002Frefractory AA\n\n   1. Poor Graft Function defined as follows:≥95% donor chimerism at last reading OR ≥95% CD3 negative chimerism; ≥2 Lineage cytopenias defined as:\n\n      Thrombocytopenia:\n      * 30x109 \u002FL from D40-D60 OR\n      * 50 x10 9\u002FL from D60 onwards; Neutropenia requiring filgrastim support at any time post D40; Hb less than 80g\u002FL;\n   2. Relapsed \u002FRefractory AA defined as: Relapse after stem cell transplant OR relapsed post\u002Frefractory to 1st line immunosuppression without an unrelated donor identified.\n2. Age ≥18\n3. ECOG performance status 0-1\n4. Life expectancy greater than 6 months\n5. Patient's written informed consent\n\nExclusion Criteria:\n\n1. Active Grade 3-4 acute GVHD\n2. Relapsed or progressive disease on screening bone marrow biopsy or most recent PET imaging.\n3. Active second malignancy currently requiring treatment\n4. Human Immuno-deficiency Virus (HIV) infection.\n5. Any coexisting medical or psychological condition that would preclude participation in the required study procedures.\n6. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug",{"count":74,"type":20},20,[51,76],"PHASE2","Allogeneic stem cell transplantation involves the transplanting of donor blood stem cells into a recipient, this is performed mainly for the treatment of blood cancers. The bone marrow is the organ that produces all blood cells and allogeneic stem cell transplantation results in the replacement of abnormal recipient bone marrow with donor blood cells as well as the production of donor immune cells from the donor bone marrow. The production of donor immune cells will hopefully lead to an immune response directed at any persisting cancerous cells leading to their eradication. As such, one of the key measures of success of a transplant is establishment of donor engraftment.\n\nEngraftment is considered successful when the patient has normal blood cell counts on routine laboratory testing as well as confirmation that the blood cells are being produced by donor bone marrow cells. Confirming donor blood cell production is done by a process called chimerism. Poor graft function (PGF) is a complication of allogeneic stem cell transplantation related to engraftment, manifested by low blood counts despite complete donor chimerism. This has significant consequences for the patient leaving them susceptible to infection because of low white blood cells and bleeding because of low platelets (the cell components that are important for blood clotting). There is currently no established treatment for this condition and patients with this condition who do not recover have a poor survival.\n\nAplastic anaemia (AA) is a rare autoimmune condition that results in a patient's own immune system attacking important components of their bone marrow resulting in low blood counts. The current treatments for AA include suppressing the immune system or a bone marrow transplant, however long term survival for patients who do not respond to these treatments or relapse is poor and more effective treatments are required.\n\nThere is emerging evidence that demonstrates that the components of the immune system are dysfunctional and result in excessive immune activation resulting in suppression of the bone marrow characteristic of PGF. Similar features of immune dysfunction has been demonstrated in AA. Ruxolitinib is a drug that may be able to reduce this excessive immune activation. Eltrombopag is a drug that has been shown to stimulate the production of blood cells. The aim of this study is to evaluate whether the combination of ruxolitinib and eltrombopag is safe and effective in the treatment of PGF and AA.",[27,79],"Aplastic Anemia Idiopathic","NOT_YET_RECRUITING","2024-09-18",{"date":83,"type":32},"2024-09-23",{"date":85,"type":20},"2024-10-30",{"date":87,"type":20},"2026-10-30",{"name":89,"class":39},"Melbourne Health",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100508982","phase-3-decitabine-for-poor-graft-function-post-allo-hsct-100508982","NCT05907499","Decitabine for Poor Graft Function Post Allo-HSCT","Low Dose Decitabine for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109\u002FL, platelet count ≤ 30 × 109\u002FL, hemoglobin ≤ 85g\u002FL, lasting for more than 2 consecutive weeks;\n2. Full donor chimerism;\n3. Primary disease in remission;\n4. No severe GVHD and relapse;\n5. ECOG: 0-2;\n6. Expected survival longer than 1 month\n\nExclusion Criteria:\n\n1. Allergic to decitabine;\n2. Active infections;\n3. Uncontrolled GVHD;\n4. Severe organ dysfunction;\n5. Relapse of underlying malignancies;\n6. Graft failure;\n7. Received decitabine or participated in other clinical trials within one month before screening.","16 Years","70 Years",{"count":100,"type":20},76,[102],"PHASE3","This randomized trial aims at validating the efficacy and safety of low-dose decitabine for PGF post allo-HSCT.",[27],[106,107],"poor graft function","hematopoietic stem cell transplantation","2023-06-08",{"date":110,"type":32},"2023-06-18",{"date":112,"type":20},"2023-07-01",{"date":114,"type":20},"2026-11-01",{"name":116,"class":39},"The First Affiliated Hospital of Soochow University",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":135,"locationsCount":4},"100490665","phase-3-decitabine-and-umbilical-cord-blood-for-poor-graft-function-post-allo-hsct-100490665","NCT05669079","Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allo-HSCT","Decitabine and Umbilical Cord Blood for Poor Graft Function Post Allogenic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Diagnosed as PGF at day 28 post-HSCT or later. PGF was defined as two or three cytopenias, absolute neutrophil count ≤ 1.5 × 109\u002FL, platelet count ≤ 30 × 109\u002FL, hemoglobin ≤ 85g\u002FL, lasting for more than 2 consecutive weeks;\n2. Full donor chimerism;\n3. Primary disease in remission;\n4. No severe GVHD and relapse.\n\nExclusion Criteria:\n\n1. Allergic to decitabine or any components of frozen preservation of umbilical cord blood;\n2. Active infections;\n3. Uncontrolled GVHD;\n4. Severe organ dysfunction;\n5. Relapse of underlying malignancies;\n6. Graft failure;\n7. Received decitabine or participated in other clinical trials within one month before screening.","65 Years",{"count":126,"type":20},100,[102],"This randomized trial aimed at validating the efficacy and safety of low-dose decitabine, together with umbilical cord blood in PGF post allo-HSCT patients.",[27],{"date":131,"type":32},"2023-06-09",{"date":133,"type":20},"2023-08-01",{"date":114,"type":20},{"name":116,"class":39}]