[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540501":3},{"organization":4,"armGroups":7,"interventions":68,"overallOfficials":694,"centralContacts":125,"locations":699,"responsibleParty":2345,"collaborators":125,"id":2347,"slug":125,"hasResults":2348,"nctId":2349,"briefTitle":2350,"officialTitle":2351,"acronym":125,"eligibilityCriteria":2352,"healthyVolunteers":2348,"sex":2353,"minAge":125,"maxAge":2354,"enrollmentInfo":2355,"targetDuration":125,"studyType":2358,"phases":2359,"briefSummary":2361,"conditions":2362,"keywords":125,"overallStatus":702,"whyStopped":125,"lastUpdateSubmitDate":2365,"lastUpdatePostDateStruct":2366,"startDateStruct":2369,"completionDateStruct":2371,"leadSponsor":2373,"locationsCount":2374},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8,35,40,44,48,52,60,64],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","EXPERIMENTAL","See Detailed Description for Arm A.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"Drug: Asparaginase Erwinia chrysanthemi","Procedure: Biospecimen Collection","Biological: Blinatumomab","Procedure: Bone Marrow Aspiration","Drug: Calaspargase Pegol","Procedure: Computed Tomography","Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Daunorubicin","Drug: Dexamethasone","Procedure: Echocardiography Test","Procedure: FDG-Positron Emission Tomography","Drug: Leucovorin","Drug: Levoleucovorin","Procedure: Lumbar Puncture","Procedure: Magnetic Resonance Imaging","Drug: Mercaptopurine","Drug: Methotrexate","Procedure: Multigated Acquisition Scan","Drug: Therapeutic Hydrocortisone","Drug: Thioguanine","Drug: Vincristine",{"label":36,"type":10,"description":37,"interventionNames":38},"Arm B, Cohort 1","See Detailed Description for Arm B, Cohort 1.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,39,34],"Drug: Venetoclax",{"label":41,"type":10,"description":42,"interventionNames":43},"Arm B, Cohort 2","See Detailed Description for Arm B, Cohort 2.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,39,34],{"label":45,"type":10,"description":46,"interventionNames":47},"Arm B, Cohort 3","See Detailed Description for Arm B, Cohort 3.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,39,34],{"label":49,"type":10,"description":50,"interventionNames":51},"Arm B, Cohort 4","See Detailed Description for Arm B, Cohort 4.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,39,34],{"label":53,"type":10,"description":54,"interventionNames":55},"Arm C","See Detailed Description for Arm C.",[14,15,16,17,18,19,20,21,22,56,23,24,25,26,27,28,29,30,57,31,58,59,32,33,34],"Drug: Doxorubicin","Drug: Methylprednisolone","Drug: Prednisolone","Drug: Prednisone",{"label":61,"type":10,"description":62,"interventionNames":63},"Safety Phase Cohort","See Detailed Description for Safety Phase Cohort.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,39,34],{"label":65,"type":10,"description":66,"interventionNames":67},"Steroid Prephase(prednisone, prednisolone, methylprednisolone)","All patients receive prednisone or prednisolone PO or NG TID or methylprednisolone IV TID for 7 days prior to the start of induction therapy (on days 1-7).",[14,16,18,23,24,27,28,57,31,58,59],[69,93,103,121,126,136,153,198,235,245,315,323,330,338,343,353,360,380,420,461,495,513,570,616,644,672,686],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DRUG","Asparaginase Erwinia chrysanthemi","Given recombinant crisantaspase IM or crisantaspase IM or IV",[9,36,41,45,49,61],[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"Asparaginase Erwinia chrysanthemi (Recombinant)-rywn","Asparaginase Erwinia chrysanthemi, Recombinant-rywn","Asparaginase Erwinia chrysanthemi-rywn","Crisantaspase","Crisantaspase Biobetter JZP-458","Crisantaspasum","Enrylaze","Erwinase","Erwinaze","JZP 458","JZP-458","JZP458","PF743","RC-P JZP-458","Recombinant Asparaginase erwinia chrysanthemi JZP-458","Recombinant Crisantaspase JZP-458","Recombinant Erwinia asparaginase JZP-458","Rylaze",{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9,36,41,45,49,53,61,65],[99,100,101,102],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"BIOLOGICAL","Blinatumomab","Given IV",[9,36,41,45,49,53,61],[109,110,111,112,113,114,115,116,117,118,119,120],"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":94,"name":122,"description":123,"armGroupLabels":124,"otherNames":125},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,36,41,45,49,53,61,65],null,{"type":70,"name":127,"description":106,"armGroupLabels":128,"otherNames":129},"Calaspargase Pegol",[9,36,41,45,49,53,61],[130,131,132,133,134,135],"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":94,"name":137,"description":138,"armGroupLabels":139,"otherNames":140},"Computed Tomography","Undergo CT",[9,36,41,45,49,53,61,65],[141,142,143,144,145,146,147,148,149,150,151,152],"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":70,"name":154,"description":106,"armGroupLabels":155,"otherNames":156},"Cyclophosphamide",[9,36,41,45,49,53,61],[157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Asta B 518","B 518","B-518","B518","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR 138719","WR- 138719","WR-138719","WR138719",{"type":70,"name":199,"description":200,"armGroupLabels":201,"otherNames":202},"Cytarabine","Given IT or IV",[9,36,41,45,49,53,61],[203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234],".beta.-Cytosine 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":70,"name":236,"description":106,"armGroupLabels":237,"otherNames":238},"Daunorubicin",[9,36,41,45,49,53,61],[239,240,241,242,243,244],"Daunomycin","Daunorrubicina","DNR","Leukaemomycin C","Rubidomycin","Rubomycin C",{"type":70,"name":246,"description":247,"armGroupLabels":248,"otherNames":249},"Dexamethasone","Given PO or NG or IV",[9,36,41,45,49,53,61],[250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314],"Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone 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":70,"name":316,"description":106,"armGroupLabels":317,"otherNames":318},"Doxorubicin",[53],[319,320,321,322],"Adriablastin","Hydroxydaunomycin","Hydroxyl Daunorubicin","Hydroxyldaunorubicin",{"type":94,"name":324,"description":325,"armGroupLabels":326,"otherNames":327},"Echocardiography Test","Undergo ECHO",[9,36,41,45,49,53,61,65],[328,329],"EC","Echocardiography",{"type":94,"name":331,"description":332,"armGroupLabels":333,"otherNames":334},"FDG-Positron Emission Tomography","Undergo FDG-PET",[9,36,41,45,49,53,61,65],[335,336,337],"FDG","FDG-PET","FDG-PET Imaging",{"type":70,"name":339,"description":247,"armGroupLabels":340,"otherNames":341},"Leucovorin",[9,36,41,45,49,53,61],[342],"Folinic acid",{"type":70,"name":344,"description":106,"armGroupLabels":345,"otherNames":346},"Levoleucovorin",[9,36,41,45,49,53,61],[347,348,349,350,351,352],"CL-307,782","Elvorine, Isovorin, Levofolene, Levorin","Isovorin","L-Leucovorin","Levofolinate","Levofolinic acid",{"type":94,"name":354,"description":355,"armGroupLabels":356,"otherNames":357},"Lumbar Puncture","Undergo lumbar puncture",[9,36,41,45,49,53,61,65],[358,359],"LP","Spinal Tap",{"type":94,"name":361,"description":362,"armGroupLabels":363,"otherNames":364},"Magnetic Resonance Imaging","Undergo MRI",[9,36,41,45,49,53,61,65],[365,366,367,368,369,370,371,372,373,374,375,376,377,378,379],"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":70,"name":381,"description":382,"armGroupLabels":383,"otherNames":384},"Mercaptopurine","Given PO or NG",[9,36,41,45,49,53,61],[385,386,387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419],"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":70,"name":421,"description":422,"armGroupLabels":423,"otherNames":424},"Methotrexate","Given IT or IV or PO or NG",[9,36,41,45,49,53,61],[425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460],"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":70,"name":462,"description":106,"armGroupLabels":463,"otherNames":464},"Methylprednisolone",[53,65],[465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487,488,489,490,491,492,493,494],"Adlone","Caberdelta M","DepMedalone","Depo Moderin","Depo-Nisolone","Duralone","Emmetipi","Esametone","Firmacort","Medlone 21","Medrate","Medrol","Medrol Veriderm","Medrone","Mega-Star","Meprolone","Methylprednisolonum","Metilbetasone Solubile","Metrocort","Metypresol","Metysolon","Predni-M-Tablinen","Prednilen","Radilem","Sieropresol","Solpredone","Summicort","Urbason","Veriderm Medrol","Wyacort",{"type":94,"name":496,"description":497,"armGroupLabels":498,"otherNames":499},"Multigated Acquisition Scan","Undergo MUGA",[9,36,41,45,49,53,61,65],[500,501,502,503,504,505,506,507,508,509,510,511,512],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","Radionuclide Ventriculography","RNV Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",{"type":70,"name":514,"description":382,"armGroupLabels":515,"otherNames":516},"Prednisolone",[53,65],[517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569],"(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":70,"name":571,"description":382,"armGroupLabels":572,"otherNames":573},"Prednisone",[53,65],[574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603,604,605,606,607,608,609,610,611,612,613,614,615],".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":70,"name":617,"description":618,"armGroupLabels":619,"otherNames":620},"Therapeutic Hydrocortisone","Given IT",[9,36,41,45,49,53,61],[621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643],"Aeroseb-HC","Barseb HC","Barseb-HC","Cetacort","Cort-Dome","Cortef","Cortenema","Cortifan","Cortisol","Cortispray","Cortril","Dermacort","Domolene","Eldecort","Hautosone","Heb-Cort","Hydrocortisone","Hydrocortone","Hytone","Komed-HC","Nutracort","Proctocort","Rectoid",{"type":70,"name":645,"description":382,"armGroupLabels":646,"otherNames":647},"Thioguanine",[9,36,41,45,49,53,61],[648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671],"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":70,"name":673,"description":382,"armGroupLabels":674,"otherNames":675},"Venetoclax",[36,41,45,49,61],[676,677,678,679,680,681,682,683,684,685],"ABT 199","ABT-0199","ABT-199","ABT199","GDC 0199","GDC-0199","GDC0199","RG7601","Venclexta","Venclyxto",{"type":70,"name":687,"description":106,"armGroupLabels":688,"otherNames":689},"Vincristine",[9,36,41,45,49,53,61],[690,691,692,693],"LCR","Leurocristine","VCR","Vincrystine",[695],{"name":696,"affiliation":697,"role":698},"Erin H Breese","Children's Oncology Group","PRINCIPAL_INVESTIGATOR",[700,722,738,753,768,783,797,812,824,839,853,867,883,898,913,929,945,961,976,988,1002,1017,1029,1038,1052,1067,1082,1096,1112,1127,1143,1158,1170,1184,1196,1210,1225,1241,1256,1271,1286,1298,1314,1329,1341,1356,1371,1386,1401,1413,1428,1443,1459,1474,1485,1500,1516,1532,1547,1561,1575,1590,1605,1620,1634,1647,1658,1668,1682,1696,1711,1725,1741,1755,1769,1784,1798,1814,1829,1844,1858,1872,1887,1903,1919,1934,1949,1964,1979,1995,2007,2023,2038,2053,2067,2078,2094,2109,2123,2135,2150,2165,2180,2195,2207,2223,2238,2253,2268,2283,2298,2314,2329],{"facility":701,"status":702,"city":703,"state":704,"zip":705,"country":706,"countryCode":707,"cosmosGeoPoint":708,"geoPoint":713,"contacts":714},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":709,"coordinates":710},"Point",[711,712],-86.80249,33.52066,{"lat":712,"lon":711},[715,720],{"name":716,"role":717,"phone":718,"phoneExt":125,"email":719},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":721,"role":698,"phone":125,"phoneExt":125,"email":125},"Matthew A. 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Long",{"facility":2315,"status":702,"city":2316,"state":2301,"zip":2317,"country":706,"countryCode":707,"cosmosGeoPoint":2318,"geoPoint":2322,"contacts":2323},"Children's Hospital of Wisconsin","Milwaukee","53226",{"type":709,"coordinates":2319},[2320,2321],-87.90647,43.0389,{"lat":2321,"lon":2320},[2324,2327],{"name":716,"role":717,"phone":2325,"phoneExt":125,"email":2326},"414-955-4727","MACCCTO@mcw.edu",{"name":2328,"role":698,"phone":125,"phoneExt":125,"email":125},"Zachary Graff",{"facility":2330,"status":702,"city":2331,"state":125,"zip":2332,"country":2333,"countryCode":2334,"cosmosGeoPoint":2335,"geoPoint":2339,"contacts":2340},"University Pediatric Hospital","San Juan","00926","Puerto Rico","PR",{"type":709,"coordinates":2336},[2337,2338],-66.10572,18.46633,{"lat":2338,"lon":2337},[2341,2343],{"name":716,"role":717,"phone":2342,"phoneExt":125,"email":125},"787-474-0333",{"name":2344,"role":698,"phone":125,"phoneExt":125,"email":125},"Maria E. Echevarria",{"type":2346,"investigatorFullName":125,"investigatorTitle":125,"investigatorAffiliation":125,"oldNameTitle":125,"oldOrganization":125},"SPONSOR","100540501",false,"NCT06317662","Testing the Addition of the Anti-cancer Drug Venetoclax and\u002For the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321\n* Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be \\> 36 weeks gestational age at the time of enrollment\n* Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization \\[WHO\\] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage\n\n  * Diagnostic immunophenotype: Leukemia cells must express CD19\n\nExclusion Criteria:\n\n* Patients with Down Syndrome\n* Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy\n* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:\n\n  * Steroid pretreatment:\n\n    * PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility\n    * Inhaled and topical steroids are not considered pretreatment\n    * Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred \\> 28 days before enrollment does not affect eligibility\n  * Intrathecal cytarabine or methotrexate:\n\n    * An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility\n    * Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status\n  * Hydroxyurea:\n\n    * Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility\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 National Cancer Institute (NCI) requirements for human studies must be met","ALL","365 Days",{"count":2356,"type":2357},153,"ESTIMATED","INTERVENTIONAL",[2360],"PHASE2","This phase II trial tests the addition of venetoclax and\u002For blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \\[R\\]) or without a KMT2A gene rearrangement (KMT2A-germline \\[G\\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs 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. Adding venetoclax and\u002For blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and\u002For blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.",[2363,2364],"Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia","2026-06-10",{"date":2367,"type":2368},"2026-06-11","ACTUAL",{"date":2370,"type":2368},"2025-06-05",{"date":2372,"type":2357},"2028-12-31",{"name":5,"class":6},113]