[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583131":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":60,"centralContacts":99,"locations":105,"responsibleParty":122,"collaborators":60,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":60,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":132,"minAge":60,"maxAge":133,"enrollmentInfo":134,"targetDuration":60,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":60,"overallStatus":108,"whyStopped":60,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8,18,26,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Closed","EXPERIMENTAL","Arm A Matched sib regimen - Age 6 -55 (per physician preference for patients over 6) Campath\u002FTBI",[13,14,15,16,17],"Drug: Alemtuzumab","Radiation: Total Body Irradiation","Biological: Cell Infusion","Drug: Sirolimus","Drug: Mycophenolate Mofetil",{"label":19,"type":10,"description":20,"interventionNames":21},"Arm B","Arm B Matched sib regimen - 0-55 (per physician preference for patients over 6) ATG\u002FFlu\u002FBu",[15,22,23,24,25,17],"Drug: Thymoglobulin","Drug: Fludarabine","Drug: Busulfan","Drug: Tacrolimus",{"label":27,"type":10,"description":28,"interventionNames":29},"Arm C","Arm C Fully Matched unrelated donor (MUD)- - 0-55 years; ATG\u002FFlu\u002FBu",[15,22,23,24,25,17,30],"Drug: Plerixafor (mozobil)",{"label":32,"type":10,"description":33,"interventionNames":34},"Arm D","Arm D: Haploindentical or mismatched unrelated donors (MMUD) - 0-55 years; ATG\u002FThiotepa\u002FCyclophosphamide\u002FMESNA\u002FFlu\u002FTBI",[16,25,30],{"label":36,"type":10,"description":37,"interventionNames":38},"Arm E","Matched sib regimen - Age 6-55 (per physician preference for patients over 6) Campath\u002FTBI with peripheral blood stem cell graft",[14,15,22,23,39,16,25,17],"Drug: Cyclophosphamide",[41,48,55,61,67,71,75,81,85,89,95],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Alemtuzumab","Alemtuzumab (Campath) will be administered IV over 2 hours on day -8 to day -4.",[9],[47],"Campath",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"RADIATION","Total Body Irradiation","400 cGy in 2 split fractions will be administered per Department of RadiationOncology SOPs.",[9,36],[54],"TBI",{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"BIOLOGICAL","Cell Infusion","On day 0 the cells will be infused per cell source specific institutional guidelines",[9,19,27,36],null,{"type":42,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Thymoglobulin","ATG will be administered IV every 24 hours beginning on day -8 for all patients.\n\nDosing will be model-based using Bayesian methodology13,14,15. Total doses and total number of doses (1-4 doses) will be determined based on absolute lymphocyte count and weight.",[19,27,36],[66],"Rabbit ATG",{"type":42,"name":68,"description":69,"armGroupLabels":70,"otherNames":60},"Fludarabine","Fludarabine will be administered IV over 1 hour every 24 hours on day -5 to day - 2. The daily dose of fludarabine will be determined by model-based dosing utilizing Bayesian methodology with a cumulative area under the curve (cAUC) of 20 mg\\*hr\u002FL (range 18-22 mg\\*hr\u002FL).",[19,27,36],{"type":42,"name":72,"description":73,"armGroupLabels":74,"otherNames":60},"Busulfan","Busulfan dosing and administration and therapeutic drug monitoring (TDM) per institutional guidelines. Initial busulfan dosing will be determined by model-based dosing utilizing Bayesian methods with a cumulative area under the curve (cAUC) of 75 mg\\*hr\u002FL.",[19,27],{"type":42,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Cyclophosphamide","Cyclophosphamide will be administered at a dose of 14.5 mg\u002Fkg over 2 hours IV daily on days -6 and -5. Cyclophosphamide dosing is calculated based on actual body weight (ABW).\n\nFor Arm D - Cyclophosphamide 50 mg\u002Fkg IV will be administered over 2 hours on days +3 and\n\n+4. Cyclophosphamide dosing for post-transplant is calculated based on ideal body weight (IBW) unless patient weighs less than IBW, in which case actual body weight (ABW) will be used.",[36],[80],"Cyclophosphamide with MESNA",{"type":42,"name":82,"description":83,"armGroupLabels":84,"otherNames":60},"Sirolimus","Patients on Arm A and Arm D will receive sirolimus; beginning on day -3 and continuing until day +180 for patients on Arm A or beginning on day +5 and continuing until 1 year post transplant for patients on Arm D.",[9,32,36],{"type":42,"name":86,"description":87,"armGroupLabels":88,"otherNames":60},"Tacrolimus","Patients on Arm B and Arm C will receive tacrolimus, beginning on day -3 and continuing until day +180. Tacrolimus dosing and monitoring will be per institutional guidelines.",[19,27,32,36],{"type":42,"name":90,"description":91,"armGroupLabels":92,"otherNames":93},"Mycophenolate Mofetil","MMF will begin on day -3 (Arm A, B \\& C) or day +5 (Arm D). Patients treated on adult service will receive 15 mg\u002Fkg (max 1500 mg\u002Fdose) given every 12 hours, rounded to nearest 250 mg. Patients on pediatric service will receive 15 mg\u002Fkg (max 1000 mg\u002Fdose) given every 8 hours. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. MMF will be stopped at day +30 (Arms A, B \\& C) or day +35 (Arm D) or 7 days after engraftment, whichever day is later, if no acute GVHD.",[9,19,27,36],[94],"(MMF)",{"type":42,"name":96,"description":97,"armGroupLabels":98,"otherNames":60},"Plerixafor (mozobil)","Plerixafor will beused to significantly increase stem cell yields on a second collection day compared to donors who continued mobilization on G-CSF only.",[27,32],[100],{"name":101,"role":102,"phone":103,"phoneExt":60,"email":104},"Ashish Gupta, MBBS, MPH","CONTACT","612-626-2961","gupta461@umn.edu",[106],{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Masonic Cancer Center","RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":115,"coordinates":116},"Point",[117,118],-93.26384,44.97997,{"lat":118,"lon":117},[121],{"name":101,"role":102,"phone":60,"phoneExt":60,"email":60},{"type":123,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100583131","phase-2-allo-hsct-for-high-risk-hemoglobinopathies-100583131",false,"NCT06872333","Allo HSCT for High Risk Hemoglobinopathies","Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders","Inclusion Criteria:\n\n* Sickle Cell Disease (SCD)\n* SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents\u002Fpatient must be counseled as to the risks and benefits and provide their voluntary informed consent\n* Transfusion Dependent Alpha- or Beta- Thalassemia\n* Diamond Blackfan Anemia\n* Other Non-Malignant Hematologic Disorders\n* Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.\n* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 30 days of the start of treatment\n* HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established prior to transplantation.\n* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted\n* Known allergy to any of the study components\n* Psychiatric illness\u002Fsocial situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study",true,"ALL","55 Years",{"count":135,"type":136},62,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.",[142,143,144],"Graft Failure","Sickle Cell Disease","Hemoglobinopathies","2026-06-01",{"date":147,"type":148},"2026-06-04","ACTUAL",{"date":150,"type":148},"2024-11-19",{"date":152,"type":136},"2032-06-01",{"name":5,"class":6},1]