[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100359362":3},{"organization":4,"armGroups":7,"interventions":51,"overallOfficials":679,"centralContacts":84,"locations":683,"responsibleParty":3829,"collaborators":3831,"id":3835,"slug":84,"hasResults":3836,"nctId":3837,"briefTitle":3838,"officialTitle":3839,"acronym":84,"eligibilityCriteria":3840,"healthyVolunteers":3836,"sex":3841,"minAge":3842,"maxAge":3843,"enrollmentInfo":3844,"targetDuration":84,"studyType":3847,"phases":3848,"briefSummary":3850,"conditions":3851,"keywords":84,"overallStatus":686,"whyStopped":84,"lastUpdateSubmitDate":3857,"lastUpdatePostDateStruct":3858,"startDateStruct":3861,"completionDateStruct":3863,"leadSponsor":3865,"locationsCount":3866},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,33,39,43],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm D (CD 22 positive HR B-ALL)","ACTIVE_COMPARATOR","See detailed description for Arm D.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32],"Procedure: Biospecimen Collection","Biological: Blinatumomab","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Drug: Calaspargase Pegol","Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Daunorubicin Hydrochloride","Drug: Dexamethasone","Drug: Doxorubicin Hydrochloride","Drug: Leucovorin Calcium","Drug: Mercaptopurine","Drug: Methotrexate","Drug: Pegaspargase","Drug: Prednisolone","Drug: Prednisone","Other: Questionnaire Administration","Radiation: Radiation Therapy","Drug: Thioguanine","Drug: Vincristine Sulfate",{"label":34,"type":35,"description":36,"interventionNames":37},"Arm E (CD22 positive HR B-ALL)","EXPERIMENTAL","See detailed description for Arm E.",[13,14,15,16,17,18,19,20,21,22,38,23,24,25,26,27,28,29,30,32],"Biological: Inotuzumab Ozogamicin",{"label":40,"type":35,"description":41,"interventionNames":42},"Arm I (MPAL)","See Detailed Description for Arm I.",[13,15,16,17,18,19,20,21,23,24,25,26,27,28,29,30,31,32],{"label":44,"type":35,"description":45,"interventionNames":46},"Arm II (B-LLy)","See Detailed Description for Arm II.",[13,15,16,47,17,48,18,19,20,21,22,23,49,24,25,26,50,27,28,29,30,31,32],"Procedure: Bone Scan","Procedure: Computed Tomography","Procedure: Magnetic Resonance Imaging","Procedure: Positron Emission Tomography",[52,62,80,85,92,98,109,126,171,208,227,297,326,336,382,402,442,483,497,509,566,612,617,635,639,667],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,34,40,44],[58,59,60,61],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"BIOLOGICAL","Blinatumomab","Given IV",[9,34],[68,69,70,71,72,73,74,75,76,77,78,79],"AMG 103","AMG-103","AMG103","Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody","Anti-CD19\u002FAnti-CD3 Recombinant Bispecific Monoclonal Antibody MT103","Blincyto","MEDI 538","MEDI-538","MEDI538","MT 103","MT-103","MT103",{"type":53,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,34,40,44],null,{"type":53,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[9,34,40,44],[90,91],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":53,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Bone Scan","Undergo bone scan",[44],[97],"Bone Scintigraphy",{"type":99,"name":100,"description":65,"armGroupLabels":101,"otherNames":102},"DRUG","Calaspargase Pegol",[9,34,40,44],[103,104,105,106,107,108],"Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)","Asparlas","Calaspargase Pegol-mknl","EZN-2285","SC-PEG E. Coli L-Asparaginase","Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase",{"type":53,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Computed Tomography","Undergo CT",[44],[114,115,116,117,118,119,120,121,122,123,124,125],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":99,"name":127,"description":65,"armGroupLabels":128,"otherNames":129},"Cyclophosphamide",[9,34,40,44],[130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Asta B 518","B 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arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-Cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453",{"type":99,"name":209,"description":65,"armGroupLabels":210,"otherNames":211},"Daunorubicin Hydrochloride",[9,34,40,44],[212,213,214,215,216,217,218,219,220,221,222,223,224,225,226],"Cerubidin","Cerubidine","Cloridrato de Daunorubicina","Daunoblastin","Daunoblastina","Daunoblastine","Daunomycin 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R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Dxevo","Fluorodelta","Fortecortin","Gammacorten","Hemady","Hexadecadrol","Hexadrol","LenaDex","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex",{"type":99,"name":298,"description":65,"armGroupLabels":299,"otherNames":300},"Doxorubicin Hydrochloride",[9,34,44],[301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325],"5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)","ADM","Adriacin","Adriamycin","Adriamycin Hydrochloride","Adriamycin PFS","Adriamycin RDF","ADRIAMYCIN, HYDROCHLORIDE","Adriamycine","Adriblastina","Adriblastine","Adrimedac","Chloridrato de Doxorrubicina","DOX","DOXO-CELL","Doxolem","Doxorubicin HCl","Doxorubicin.HCl","Doxorubin","Farmiblastina","FI 106","FI-106","FI106","hydroxydaunorubicin","Rubex",{"type":63,"name":327,"description":65,"armGroupLabels":328,"otherNames":329},"Inotuzumab Ozogamicin",[34],[330,331,332,333,334,335],"Besponsa","CMC 544","CMC-544","CMC544","Way 207294","WAY-207294",{"type":99,"name":337,"description":229,"armGroupLabels":338,"otherNames":339},"Leucovorin Calcium",[9,34,40,44],[340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381],"Adinepar","Calcifolin","Calcium (6S)-Folinate","Calcium Folinate","Calcium Leucovorin","Calfolex","Calinat","Cehafolin","Citofolin","Citrec","Citrovorum Factor","Cromatonbic Folinico","Dalisol","Disintox","Divical","Ecofol","Emovis","Factor, Citrovorum","Flynoken A","Folaren","Folaxin","FOLI-cell","Foliben","Folidan","Folidar","Folinac","Folinate Calcium","folinic acid","Folinic Acid Calcium Salt Pentahydrate","Folinoral","Folinvit","Foliplus","Folix","Imo","Lederfolat","Lederfolin","Leucosar","leucovorin","Rescufolin","Rescuvolin","Tonofolin","Wellcovorin",{"type":53,"name":383,"description":384,"armGroupLabels":385,"otherNames":386},"Magnetic Resonance Imaging","Undergo MRI",[44],[387,388,389,390,391,392,393,394,395,396,397,398,399,400,401],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":99,"name":403,"description":404,"armGroupLabels":405,"otherNames":406},"Mercaptopurine","Given PO",[9,34,40,44],[407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441],"3H-Purine-6-thiol","6 MP","6 Thiohypoxanthine","6 Thiopurine","6-Mercaptopurine","6-Mercaptopurine Monohydrate","6-MP","6-Purinethiol","6-Thiopurine","6-Thioxopurine","6H-Purine-6-thione, 1,7-dihydro- (9CI)","7-Mercapto-1,3,4,6-tetrazaindene","Alti-Mercaptopurine","Azathiopurine","Bw 57-323H","Flocofil","Ismipur","Leukerin","Leupurin","Mercaleukim","Mercaleukin","Mercaptina","Mercaptopurinum","Mercapurin","Mern","NCI-C04886","Puri-Nethol","Purimethol","Purine, 6-mercapto-","Purine-6-thiol (8CI)","Purine-6-thiol, monohydrate","Purinethiol","Purinethol","U-4748","WR-2785",{"type":99,"name":443,"description":444,"armGroupLabels":445,"otherNames":446},"Methotrexate","Given IT or IV",[9,34,40,44],[447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482],"Abitrexate","Alpha-Methopterin","Amethopterin","Brimexate","CL 14377","CL-14377","Emtexate","Emthexat","Emthexate","Farmitrexat","Fauldexato","Folex","Folex PFS","Jylamvo","Lantarel","Ledertrexate","Lumexon","Maxtrex","Medsatrexate","Metex","Methoblastin","Methotrexate LPF","Methotrexate Methylaminopterin","Methotrexatum","Metotrexato","Metrotex","Mexate","Mexate-AQ","MTX","Novatrex","Rheumatrex","Texate","Tremetex","Trexeron","Trixilem","WR-19039",{"type":99,"name":484,"description":485,"armGroupLabels":486,"otherNames":487},"Pegaspargase","Given IV or IM",[9,34,40,44],[488,489,490,491,492,493,494,495,496],"L-Asparaginase with Polyethylene Glycol","Oncaspar","Oncaspar-IV","PEG-Asparaginase","PEG-L-Asparaginase","PEG-L-Asparaginase (Enzon - Kyowa Hakko)","PEGLA","Polyethylene Glycol L-Asparaginase","Polyethylene Glycol-L-Asparaginase",{"type":53,"name":498,"description":499,"armGroupLabels":500,"otherNames":501},"Positron Emission Tomography","Undergo PET",[44],[502,503,504,505,506,507,508],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":99,"name":510,"description":229,"armGroupLabels":511,"otherNames":512},"Prednisolone",[9,34,40,44],[513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565],"(11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione",".delta.1-Hydrocortisone","Adnisolone","Aprednislon","Capsoid","Cortalone","Cortisolone","Dacortin H","Decaprednil","Decortin H","Delta(1)Hydrocortisone","Delta- Cortef","Delta-Cortef","Delta-Diona","Delta-F","Delta-Phoricol","Delta1-dehydro-hydrocortisone","Deltacortril","Deltahydrocortisone","Deltasolone","Deltidrosol","Dhasolone","Di-Adreson-F","Dontisolon D","Estilsona","Fisopred","Frisolona","Gupisone","Hostacortin H","Hydeltra","Hydeltrasol","Klismacort","Kuhlprednon","Lenisolone","Lepi-Cortinolo","Linola-H N","Linola-H-Fett N","Longiprednil","Metacortandralone","Meti Derm","Meticortelone","Opredsone","Panafcortelone","Precortisyl","Pred-Clysma","Predeltilone","Predni-Coelin","Predni-Helvacort","Prednicortelone","Prednisolonum","Prelone","Prenilone","Sterane",{"type":99,"name":567,"description":229,"armGroupLabels":568,"otherNames":569},"Prednisone",[9,34,40,44],[570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611],".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone",{"type":613,"name":614,"description":615,"armGroupLabels":616,"otherNames":84},"OTHER","Questionnaire Administration","Ancillary studies",[9,34,40,44],{"type":618,"name":619,"description":620,"armGroupLabels":621,"otherNames":622},"RADIATION","Radiation Therapy","Undergo testicular radiation therapy",[9,34,40,44],[623,624,625,626,627,628,629,630,631,632,633,634],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":618,"name":619,"description":636,"armGroupLabels":637,"otherNames":638},"Undergo cranial radiation therapy",[9,34,40,44],[623,624,625,626,627,628,629,630,631,632,633,634],{"type":99,"name":640,"description":404,"armGroupLabels":641,"otherNames":642},"Thioguanine",[9,40,44],[643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666],"2-Amino 6MP","2-Amino-1,7-dihydro-6H-purine-6-thione","2-Amino-6-mercaptopurine","2-Amino-6-purinethiol","2-Aminopurin-6-thiol","2-Aminopurine-6(1H)-thione","2-Aminopurine-6-thiol","2-Aminopurine-6-thiol Hemihydrate","2-Mercapto-6-aminopurine","6-Amino-2-mercaptopurine","6-Mercapto-2-aminopurine","6-Mercaptoguanine","6-TG","6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)","BW 5071","Lanvis","Tabloid","Thioguanine Hemihydrate","Thioguanine Hydrate","Tioguanin","Tioguanine","Wellcome U3B","WR-1141","X 27",{"type":99,"name":668,"description":65,"armGroupLabels":669,"otherNames":670},"Vincristine Sulfate",[9,34,40,44],[671,672,673,674,675,676,677,678],"Kyocristine","Leurocristine Sulfate","Leurocristine, sulfate","Oncovin","Vincasar","Vincosid","Vincrex","Vincristine, sulfate",[680],{"name":681,"affiliation":5,"role":682},"Jennifer L McNeer","PRINCIPAL_INVESTIGATOR",[684,706,720,736,751,765,779,794,809,824,838,852,866,878,885,900,915,927,942,957,971,982,996,1007,1021,1035,1045,1061,1076,1091,1106,1122,1132,1144,1158,1173,1187,1202,1214,1223,1237,1248,1254,1269,1281,1290,1304,1309,1324,1339,1351,1365,1381,1396,1411,1426,1441,1457,1472,1483,1495,1509,1523,1535,1550,1559,1573,1588,1600,1616,1630,1646,1661,1676,1691,1703,1718,1733,1748,1759,1771,1785,1795,1806,1817,1831,1846,1861,1874,1880,1889,1904,1916,1930,1946,1957,1971,1986,2002,2017,2031,2043,2054,2069,2080,2090,2096,2108,2117,2130,2146,2161,2175,2188,2204,2215,2230,2245,2261,2272,2287,2301,2316,2331,2345,2358,2370,2382,2393,2403,2416,2430,2444,2459,2473,2489,2504,2518,2530,2544,2559,2573,2589,2604,2619,2633,2645,2660,2674,2689,2705,2719,2734,2746,2762,2777,2791,2806,2817,2832,2847,2863,2877,2889,2905,2920,2934,2948,2959,2969,2984,2999,3013,3025,3040,3055,3070,3081,3096,3107,3122,3137,3149,3160,3174,3189,3205,3221,3236,3251,3265,3280,3295,3310,3325,3340,3346,3360,3369,3378,3394,3409,3424,3439,3451,3460,3475,3491,3506,3521,3535,3553,3568,3584,3600,3616,3632,3647,3662,3676,3690,3705,3721,3736,3752,3758,3773,3790,3804,3815],{"facility":685,"status":686,"city":687,"state":688,"zip":689,"country":690,"countryCode":691,"cosmosGeoPoint":692,"geoPoint":697,"contacts":698},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":693,"coordinates":694},"Point",[695,696],-86.80249,33.52066,{"lat":696,"lon":695},[699,704],{"name":700,"role":701,"phone":702,"phoneExt":84,"email":703},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":705,"role":682,"phone":84,"phoneExt":84,"email":84},"Matthew A. 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Lewis",{"facility":3554,"status":686,"city":3555,"state":3538,"zip":3556,"country":3540,"countryCode":3541,"cosmosGeoPoint":3557,"geoPoint":3561,"contacts":3562},"University of Alberta Hospital","Edmonton","T6G 2B7",{"type":693,"coordinates":3558},[3559,3560],-113.46871,53.55014,{"lat":3560,"lon":3559},[3563,3566],{"name":700,"role":701,"phone":3564,"phoneExt":84,"email":3565},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":3567,"role":682,"phone":84,"phoneExt":84,"email":84},"Sarah J. McKillop",{"facility":3569,"status":686,"city":3570,"state":3571,"zip":3572,"country":3540,"countryCode":3541,"cosmosGeoPoint":3573,"geoPoint":3577,"contacts":3578},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":693,"coordinates":3574},[3575,3576],-123.11934,49.24966,{"lat":3576,"lon":3575},[3579,3582],{"name":700,"role":701,"phone":3580,"phoneExt":3581,"email":84},"604-875-2345","6477",{"name":3583,"role":682,"phone":84,"phoneExt":84,"email":84},"Rebecca J. Deyell",{"facility":3585,"status":686,"city":3586,"state":3587,"zip":3588,"country":3540,"countryCode":3541,"cosmosGeoPoint":3589,"geoPoint":3593,"contacts":3594},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":693,"coordinates":3590},[3591,3592],-97.14704,49.8844,{"lat":3592,"lon":3591},[3595,3598],{"name":700,"role":701,"phone":3596,"phoneExt":84,"email":3597},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":3599,"role":682,"phone":84,"phoneExt":84,"email":84},"Stephanie M. Villeneuve",{"facility":3601,"status":686,"city":3602,"state":3603,"zip":3604,"country":3540,"countryCode":3541,"cosmosGeoPoint":3605,"geoPoint":3609,"contacts":3610},"Janeway Child Health Centre","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":693,"coordinates":3606},[3607,3608],-52.70931,47.56494,{"lat":3608,"lon":3607},[3611,3614],{"name":700,"role":701,"phone":3612,"phoneExt":84,"email":3613},"709-777-8727","beverlyj.mitchell@easternhealth.ca",{"name":3615,"role":682,"phone":84,"phoneExt":84,"email":84},"Lisa A. Goodyear",{"facility":3617,"status":686,"city":3618,"state":3619,"zip":3620,"country":3540,"countryCode":3541,"cosmosGeoPoint":3621,"geoPoint":3625,"contacts":3626},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":693,"coordinates":3622},[3623,3624],-63.57688,44.64269,{"lat":3624,"lon":3623},[3627,3630],{"name":700,"role":701,"phone":3628,"phoneExt":84,"email":3629},"902-470-8520","Research@iwk.nshealth.ca",{"name":3631,"role":682,"phone":84,"phoneExt":84,"email":84},"Chelsea Ash",{"facility":3633,"status":686,"city":3634,"state":3635,"zip":3636,"country":3540,"countryCode":3541,"cosmosGeoPoint":3637,"geoPoint":3641,"contacts":3642},"McMaster Children's Hospital at Hamilton Health Sciences","Hamilton","Ontario","L8N 3Z5",{"type":693,"coordinates":3638},[3639,3640],-79.84963,43.25011,{"lat":3640,"lon":3639},[3643,3645],{"name":700,"role":701,"phone":3644,"phoneExt":84,"email":84},"905-521-2100",{"name":3646,"role":682,"phone":84,"phoneExt":84,"email":84},"Uma H. Athale",{"facility":3648,"status":686,"city":3649,"state":3635,"zip":3650,"country":3540,"countryCode":3541,"cosmosGeoPoint":3651,"geoPoint":3655,"contacts":3656},"Kingston Health Sciences Centre","Kingston","K7L 2V7",{"type":693,"coordinates":3652},[3653,3654],-76.48098,44.22976,{"lat":3654,"lon":3653},[3657,3660],{"name":700,"role":701,"phone":3658,"phoneExt":84,"email":3659},"613-549-6666","cc-clinicaltrials@kgh.kari.net",{"name":3661,"role":682,"phone":84,"phoneExt":84,"email":84},"Laura Wheaton",{"facility":3663,"status":686,"city":3664,"state":3635,"zip":3665,"country":3540,"countryCode":3541,"cosmosGeoPoint":3666,"geoPoint":3670,"contacts":3671},"Children's Hospital","London","N6A 5W9",{"type":693,"coordinates":3667},[3668,3669],-81.23304,42.98339,{"lat":3669,"lon":3668},[3672,3674],{"name":700,"role":701,"phone":3673,"phoneExt":84,"email":84},"519-685-8306",{"name":3675,"role":682,"phone":84,"phoneExt":84,"email":84},"Shayna M. Zelcer",{"facility":3677,"status":686,"city":3678,"state":3635,"zip":3679,"country":3540,"countryCode":3541,"cosmosGeoPoint":3680,"geoPoint":3684,"contacts":3685},"Children's Hospital of Eastern Ontario","Ottawa","K1H 8L1",{"type":693,"coordinates":3681},[3682,3683],-75.69812,45.41117,{"lat":3683,"lon":3682},[3686,3688],{"name":700,"role":701,"phone":3687,"phoneExt":84,"email":84},"613-737-7600",{"name":3689,"role":682,"phone":84,"phoneExt":84,"email":84},"Donna L. Johnston",{"facility":3691,"status":686,"city":3692,"state":3635,"zip":3693,"country":3540,"countryCode":3541,"cosmosGeoPoint":3694,"geoPoint":3698,"contacts":3699},"Hospital for Sick Children","Toronto","M5G 1X8",{"type":693,"coordinates":3695},[3696,3697],-79.39864,43.70643,{"lat":3697,"lon":3696},[3700,3703],{"name":700,"role":701,"phone":3701,"phoneExt":84,"email":3702},"416-813-7654","ask.CRS@sickkids.ca",{"name":3704,"role":682,"phone":84,"phoneExt":84,"email":84},"Johann Hitzler",{"facility":3706,"status":686,"city":3707,"state":3708,"zip":3709,"country":3540,"countryCode":3541,"cosmosGeoPoint":3710,"geoPoint":3714,"contacts":3715},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",{"type":693,"coordinates":3711},[3712,3713],-73.58781,45.50884,{"lat":3713,"lon":3712},[3716,3719],{"name":700,"role":701,"phone":3717,"phoneExt":84,"email":3718},"514-412-4445","info@thechildren.com",{"name":3720,"role":682,"phone":84,"phoneExt":84,"email":84},"Stephanie Mourad",{"facility":3722,"status":686,"city":3723,"state":3708,"zip":3724,"country":3540,"countryCode":3541,"cosmosGeoPoint":3725,"geoPoint":3729,"contacts":3730},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",{"type":693,"coordinates":3726},[3727,3728],-71.89908,45.40008,{"lat":3728,"lon":3727},[3731,3734],{"name":700,"role":701,"phone":3732,"phoneExt":84,"email":3733},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":3735,"role":682,"phone":84,"phoneExt":84,"email":84},"Josee Brossard",{"facility":3737,"status":686,"city":3738,"state":3739,"zip":3740,"country":3540,"countryCode":3541,"cosmosGeoPoint":3741,"geoPoint":3745,"contacts":3746},"Jim Pattison Children's Hospital","Saskatoon","Saskatchewan","S7N 0W8",{"type":693,"coordinates":3742},[3743,3744],-106.66892,52.13238,{"lat":3744,"lon":3743},[3747,3750],{"name":700,"role":701,"phone":3748,"phoneExt":84,"email":3749},"306-655-3544","Jessica.Marien@saskhealthauthority.ca",{"name":3751,"role":682,"phone":84,"phoneExt":84,"email":84},"Kathleen Felton",{"facility":3753,"status":880,"city":3738,"state":3739,"zip":3754,"country":3540,"countryCode":3541,"cosmosGeoPoint":3755,"geoPoint":3757,"contacts":84},"Saskatoon Cancer Centre","S7N 4H4",{"type":693,"coordinates":3756},[3743,3744],{"lat":3744,"lon":3743},{"facility":3759,"status":686,"city":3760,"state":84,"zip":3761,"country":3540,"countryCode":3541,"cosmosGeoPoint":3762,"geoPoint":3766,"contacts":3767},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",{"type":693,"coordinates":3763},[3764,3765],-71.21454,46.81228,{"lat":3765,"lon":3764},[3768,3771],{"name":700,"role":701,"phone":3769,"phoneExt":84,"email":3770},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":3772,"role":682,"phone":84,"phoneExt":84,"email":84},"Bruno Michon",{"facility":3774,"status":686,"city":3775,"state":3776,"zip":3777,"country":3778,"countryCode":3779,"cosmosGeoPoint":3780,"geoPoint":3784,"contacts":3785},"Starship Children's Hospital","Grafton","Auckland","1145","New Zealand","NZ",{"type":693,"coordinates":3781},[3782,3783],174.76566,-36.86029,{"lat":3783,"lon":3782},[3786,3788],{"name":700,"role":701,"phone":3787,"phoneExt":84,"email":84},"0800 728 436",{"name":3789,"role":682,"phone":84,"phoneExt":84,"email":84},"Lochie R. Teague",{"facility":3791,"status":686,"city":3792,"state":84,"zip":3793,"country":3778,"countryCode":3779,"cosmosGeoPoint":3794,"geoPoint":3798,"contacts":3799},"Christchurch Hospital","Christchurch","8011",{"type":693,"coordinates":3795},[3796,3797],172.63333,-43.53333,{"lat":3797,"lon":3796},[3800,3802],{"name":700,"role":701,"phone":3801,"phoneExt":84,"email":84},"03 364 0640",{"name":3803,"role":682,"phone":84,"phoneExt":84,"email":84},"Siobhan F. Cross",{"facility":3805,"status":1037,"city":3806,"state":84,"zip":3807,"country":3808,"countryCode":3809,"cosmosGeoPoint":3810,"geoPoint":3814,"contacts":84},"HIMA San Pablo Oncologic Hospital","Caguas","00726","Puerto Rico","PR",{"type":693,"coordinates":3811},[3812,3813],-66.0485,18.23412,{"lat":3813,"lon":3812},{"facility":3816,"status":686,"city":3817,"state":84,"zip":3818,"country":3808,"countryCode":3809,"cosmosGeoPoint":3819,"geoPoint":3823,"contacts":3824},"University Pediatric Hospital","San Juan","00926",{"type":693,"coordinates":3820},[3821,3822],-66.10572,18.46633,{"lat":3822,"lon":3821},[3825,3827],{"name":700,"role":701,"phone":3826,"phoneExt":84,"email":84},"787-474-0333",{"name":3828,"role":682,"phone":84,"phoneExt":84,"email":84},"Maria E. Echevarria",{"type":3830,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR",[3832],{"name":3833,"class":3834},"National Cancer Institute (NCI)","NIH","100359362",false,"NCT03959085","Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy","Inclusion Criteria:\n\n* B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.\n* APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732.\n* Patients must be \\> 365 days and \\\u003C 25 years of age\n* Initial white blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-9.99 years: WBC \\>= 50,000\u002FuL\n  * Age 10-24.99 years: Any WBC\n  * Age 1-9.99 years: WBC \\\u003C 50,000\u002FuL with one or more of the following:\n\n    * Testicular leukemia\n    * CNS leukemia (CNS3)\n    * Steroid pretreatment.\n* Initial white blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy):\n\n  * Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.\n* Patient has newly diagnosed B-ALL or MPAL (by World Health Organization \\[WHO\\] 2016 criteria) with \\>= 25% blasts on a bone marrow (BM) aspirate;\n\n  * OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy;\n  * OR A complete blood count (CBC) documenting the presence of at least 1,000\u002FuL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.\n* Patient has newly diagnosed B-LLy Murphy stages III or IV.\n* Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.\n* Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.\n* Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction. Note that once cerebrospinal fluid (CSF) has been collected, protocol therapy can be initiated while final determination of CNS status is pending. It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.\n* Direct bilirubin \\\u003C 2.0 mg\u002FdL (34 micromoles\u002FL)\n* Alanine aminotransferase (ALT) ≤ 10x upper limit of normal (ULN). For the purposes of this study, the ULN for ALT is defined as 45 U\u002FL\n* Exceptions to this include patients with known Gilbert's Syndrome, or those with hepatic involvement from leukemic or lymphomatous infiltration\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.\n\nExclusion Criteria:\n\n* Patients with Down syndrome are not eligible\n* With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.\n* Patients who have received \\> 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.\n* Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing \\> 1,000\u002FuL circulating leukemia cells.\n* Patients with acute undifferentiated leukemia (AUL) are not eligible.\n* For Murphy stage III\u002FIV B-LLy patients, or stage I\u002FII patients with steroid pretreatment, the following additional exclusion criteria apply:\n\n  * T-lymphoblastic lymphoma.\n  * Morphologically unclassifiable lymphoma.\n  * Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.\n* Patients with known Charcot-Marie-Tooth disease.\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.\n* Patients requiring radiation at diagnosis.\n* Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.\n* Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation. For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.","ALL","365 Days","25 Years",{"count":3845,"type":3846},5951,"ESTIMATED","INTERVENTIONAL",[3849],"PHASE3","This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy and immunotherapy (chemo-immunotherapy) for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. Inotuzumab ozogamicin is a monoclonal antibody, which is a type of protein that can bind to certain targets on the surface of cells. Inotuzumab ozogamicin is a monoclonal antibody that is linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells by binding to the CD22 protein on the surface of the cancer cell and delivering calicheamicin inside the cells to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Blinatumomab is a specialized type of monoclonal antibody known as a bispecific T-cell engager (BiTE). It works by simultaneously binding to CD19 on cancer cells and CD3 on normal immune cells, bringing them together to destroy leukemia cells. Blinatumomab is a standard part of chemo-immunotherapy treatment for B-ALL. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin or blinatumomab.\n\nThe overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemo-immunotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first phase of therapy: Induction. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-induction treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (consolidation, blinatumomab block 1, interim maintenance 1, blinatumomab block 2, delayed intensification, interim maintenance 2, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of consolidation or part of delayed intensification. Other aims of this study include evaluating 1) side effects of treatment using patient-reported outcomes and health-related quality of life, 2) the best ways to help patients adhere to oral chemotherapy regimens, 3) the relationship between levels of inotuzumab ozogamicin in the blood and side effects, 4) the impact of chemo-immunotherapy on the immune system and risk of infection, and 5) the impact of social determinants of health on outcomes. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.",[3852,3853,3854,3855,3856],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia","2026-06-18",{"date":3859,"type":3860},"2026-06-22","ACTUAL",{"date":3862,"type":3860},"2019-10-31",{"date":3864,"type":3846},"2032-03-31",{"name":5,"class":6},230]