[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100150910":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":37,"centralContacts":11,"locations":44,"responsibleParty":149,"collaborators":152,"id":158,"slug":159,"hasResults":160,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":160,"sex":166,"minAge":167,"maxAge":11,"enrollmentInfo":168,"targetDuration":11,"studyType":171,"phases":172,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":187,"whyStopped":11,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Cardiff University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"AC220 Intervention","EXPERIMENTAL",null,[13],"Drug: AC220",{"label":15,"type":10,"description":11,"interventionNames":16},"Plerixafor Intervention",[17],"Drug: Plerixafor",{"label":19,"type":10,"description":11,"interventionNames":20},"Ganetespib",[21],"Drug: Ganetespib",[23,30,34],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Plerixafor","Fixed dose of Plerixafor (240mcg\u002Fkg) given by subcutaneous injection on each day of chemotherapy for up to 3 courses (depending on cohort). The three chemotherapy courses will be Daunorubicin\u002FClofarabine for courses 1\\&2 and Daunorubicin\u002FAra-C for course 3. Each course will last 5 days, and Plerixafor will be given for 5 days.",[15],[29],"Mozobil",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"AC220","Each cohort of patients will receive three courses of chemotherapy approximately 4 to 5 weeks apart which will comprise of Daunorubicin\u002FAra-C\u002FEtoposide in Courses 1\\&2 and Daunorubicin\u002FAra-C in Course 3. Two days after the last day of each chemotherapy course, patients will receive AC220 orally for 7, 14 or 21 (depending on cohort) consecutive days. Depending on which cohort the patient enters, they will receive either 60mg, 90mg or 135mg of AC220 daily, with a provision to assess 40mg if necessary.",[9],{"type":24,"name":19,"description":35,"armGroupLabels":36,"otherNames":11},"Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE\u002FDAE\u002FDA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.",[19],[38,41],{"name":39,"affiliation":5,"role":40},"Alan K Burnett","STUDY_CHAIR",{"name":42,"affiliation":43,"role":40},"Nigel H Russell","Nottingham University",[45,56,64,72,80,88,96,104,112,120,128,133,141],{"facility":46,"status":11,"city":47,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":11},"Aberdeen Royal Infirmary","Aberdeen","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-2.09814,57.14369,{"lat":54,"lon":53},{"facility":57,"status":11,"city":58,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":59,"geoPoint":63,"contacts":11},"Belfast City Hospital","Belfast",{"type":51,"coordinates":60},[61,62],-5.92541,54.59682,{"lat":62,"lon":61},{"facility":65,"status":11,"city":66,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":67,"geoPoint":71,"contacts":11},"Birmingham Heartlands Hospital","Birmingham",{"type":51,"coordinates":68},[69,70],-1.89983,52.48142,{"lat":70,"lon":69},{"facility":73,"status":11,"city":74,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"Addenbrooke's Hospital","Cambridge",{"type":51,"coordinates":76},[77,78],0.11667,52.2,{"lat":78,"lon":77},{"facility":81,"status":11,"city":82,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":87,"contacts":11},"University Hospital of Wales","Cardiff",{"type":51,"coordinates":84},[85,86],-3.18,51.48,{"lat":86,"lon":85},{"facility":89,"status":11,"city":90,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":95,"contacts":11},"Castle Hill Hospital","Hull",{"type":51,"coordinates":92},[93,94],-0.33525,53.7446,{"lat":94,"lon":93},{"facility":97,"status":11,"city":98,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":103,"contacts":11},"St James's University Hospital","Leeds",{"type":51,"coordinates":100},[101,102],-1.54785,53.79648,{"lat":102,"lon":101},{"facility":105,"status":11,"city":106,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"Royal Liverpool University Hospital","Liverpool",{"type":51,"coordinates":108},[109,110],-2.97794,53.41058,{"lat":110,"lon":109},{"facility":113,"status":11,"city":114,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"St Bartholomew's Hospital","London",{"type":51,"coordinates":116},[117,118],-0.12574,51.50853,{"lat":118,"lon":117},{"facility":121,"status":11,"city":122,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":123,"geoPoint":127,"contacts":11},"Christie Hospital","Manchester",{"type":51,"coordinates":124},[125,126],-2.23743,53.48095,{"lat":126,"lon":125},{"facility":129,"status":11,"city":122,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":130,"geoPoint":132,"contacts":11},"Manchester Royal Infirmary",{"type":51,"coordinates":131},[125,126],{"lat":126,"lon":125},{"facility":134,"status":11,"city":135,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":136,"geoPoint":140,"contacts":11},"Freeman Hospital","Newcastle",{"type":51,"coordinates":137},[138,139],-5.88979,54.21804,{"lat":139,"lon":138},{"facility":142,"status":11,"city":143,"state":11,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":144,"geoPoint":148,"contacts":11},"Nottingham University Hospital","Nottingham",{"type":51,"coordinates":145},[146,147],-1.15047,52.9536,{"lat":147,"lon":146},{"type":150,"investigatorFullName":39,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chief Investigator",[153,156],{"name":154,"class":155},"Leukaemia & Lymphoma Research Group","UNKNOWN",{"name":157,"class":6},"Experimental Cancer Medicine Centres","100150910","phase-1-a-trial-to-establish-the-feasibility-of-combining-either-the-tyrosine-kinase-inhibitor-ac220cxcr4-inhibitor-plerixafor-or-hsp90-inhibitor-ganetespib-with-chemotherapy-in-older-patients-with-acute-myeloid-leukaemia-and-high-risk-myelodysplastic-syndrome-100150910",false,"NCT01236144","A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.","An NCRI Acute Myeloid Leukaemia Working Group Pilot Trial Under the Auspices of the Cardiff Experimental Cancer Medicine Centre to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.","AML18 Pilot","Inclusion Criteria:\n\n* They have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia or CML in blast crisis as defined by the WHO Classification (Appendix A) - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2).\n* Serum creatinine ≤ 1.5 × ULN (upper limit of normal)\n* White cell count of \\\u003C30 x 109\u002FL at diagnosis (for Plerixafor option only). If WCC is \\>30 x 109\u002Fl patients in the Plerixafor pilot should have the WCC reduced to \\\u003C30 x 109\u002FL using Hydroxycarbamide to avoid the risk of hyperleucocytosis\n* Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits, and every effort should be made to keep potassium at institutional normal limits, and every effort should be made to keep potassium concentrations above 4.0 mEq\u002FdL, and serum calcium at normal concentration.\n* Total serum bilirubin ≤ 1.5 × ULN (upper limit of normal) and serum aspartate transaminase (AST) and\u002For alanine transaminase (ALT) ≤ 2.5 × ULN\n* Sexually mature males must agree to use an adequate and medically accepted method of contraception throughout the study if their sexual partners are women of child bearing potential (WOCBP).\n* Over 60 years of age\n* Provided written informed consent\n\nExclusion Criteria:\n\n* They have previously received cytotoxic chemotherapy for AML. \\[Hydroxycarbamide, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion\\].\n* They are in blast transformation of chronic myeloid leukaemia (CML).\n* They have a concurrent active malignancy excluding basal cell carcinoma.\n* They are pregnant or lactating.\n* They have Acute Promyelocytic Leukaemia\n* Known infection with human immunodeficiency virus (HIV)\n\nPatients are not eligible for the AC220 option if they have:\n\n* Uncontrolled or significant cardiovascular disease, including :\n* A myocardial infarction within 12 months\n* Uncontrolled angina within 6 months\n* Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or Multiple Gated Acquisition Scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is ≥ 45% (or institutional lower limit of normal value).\n* Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes \\[TdP\\]); any history of arrhythmia will be discussed with the Sponsor's Medical Monitor prior to patient's entry into the study.\n* Prolonged QTcF interval on pre-entry ECG (≥450 ms) - this will be the average of 3 readings within a 2 hour period.\n* Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker).\n* Heart rate \\\u003C 50\u002Fminute on pre-entry ECG\n* Uncontrolled hypertension\n* Obligate need for a cardiac pacemaker\n* Complete left bundle branch block\n* Atrial fibrillation","ALL","60 Years",{"count":169,"type":170},113,"ACTUAL","INTERVENTIONAL",[173,174],"PHASE1","PHASE2","The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to 60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients\u002Finvestigators will be able to choose which intervention to enter. Depending on recruitment requirements, only one intervention might be available at any one time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE\u002FDAE\u002FDA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.",[177,178],"Acute Myeloid Leukaemia","High Risk Myelodysplastic Syndrome",[180,181,182,183,184,82,185,186,31,25,19],"Myeloid","Leukaemia","Acute","Myelodysplastic","Pilot","Haematology","Burnett","COMPLETED","2014-06-10",{"date":190,"type":191},"2014-06-11","ESTIMATED",{"date":193,"type":11},"2011-04",{"date":195,"type":170},"2014-01",{"name":5,"class":6},13]