[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100404441":3},{"organization":4,"armGroups":7,"interventions":60,"overallOfficials":420,"centralContacts":133,"locations":425,"responsibleParty":3210,"collaborators":133,"id":3212,"slug":3213,"hasResults":3214,"nctId":3215,"briefTitle":3216,"officialTitle":3217,"acronym":133,"eligibilityCriteria":3218,"healthyVolunteers":3214,"sex":3219,"minAge":3220,"maxAge":3221,"enrollmentInfo":3222,"targetDuration":133,"studyType":3225,"phases":3226,"briefSummary":3228,"conditions":3229,"keywords":133,"overallStatus":428,"whyStopped":133,"lastUpdateSubmitDate":3232,"lastUpdatePostDateStruct":3233,"startDateStruct":3236,"completionDateStruct":3238,"leadSponsor":3240,"locationsCount":3241},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8,23,27,31,35,39,49,52,56],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm G (dexamethasone, blinatumomab, nivolumab,MTX) DS patients","EXPERIMENTAL","Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV over 30 minutes on days 11 of cycle 1 and day 3 of cycle 2, and MTX IT (for patients with CNS1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with MRD \\\u003C0.01% at the end of Cycle 1 may stop study treatment at the discretion of the treating physician. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.",[13,14,15,16,17,18,19,20,21,22],"Procedure: Biospecimen Collection","Biological: Blinatumomab","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Drug: Cytarabine","Drug: Dexamethasone","Drug: Hydrocortisone Sodium Succinate","Procedure: Lumbar Puncture","Drug: Methotrexate","Biological: Nivolumab",{"label":24,"type":10,"description":25,"interventionNames":26},"Group 1, Arm A (dexamethasone, blinatumomab, MTX)","ARM A: Patients receive dexamethasone PO or IV on days 1 and 8 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1-2, MTX IT, cytarabine IT, or ITT IT on days 1, 15, and 36 of cycle 1 (MTX, cytarabine, and ITT on day 1 may be omitted if intrathecal therapy was given \\\u003C 7 days prior to the start of this cycle), and MTX IT, cytarabine IT, or ITT IT on days 15 and 36 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9\u002F19\u002F2024)",[13,14,15,16,17,18,19,20,21],{"label":28,"type":10,"description":29,"interventionNames":30},"Group 1, Arm B (dexamethasone, blinatumomab, MTX)","Patients receive dexamethasone, blinatumomab, and MTX, cytarabine, or ITT as in Arm A. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9\u002F19\u002F2024)",[13,14,15,16,17,18,19,20,21,22],{"label":32,"type":10,"description":33,"interventionNames":34},"Group 2, Arm C (dexamethasone, blinatumomab, MTX)","Patients receive dexamethasone PO or IV on day 1 of cycle 1, blinatumomab via continuous IV infusion on days 1-28 of cycles 1 and 2, and methotrexate IT on days 1 and 15 of cycles 1 and 2 (day 1 may be omitted from cycle 1 if intrathecal therapy is given \\\u003C 7 days prior to the start of this cycle). Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9\u002F19\u002F2024)",[13,14,15,16,18,20,21],{"label":36,"type":10,"description":37,"interventionNames":38},"Group 2, Arm D (dexamethasone, nivolumab, blinatumomab, MTX)","Patients receive dexamethasone, blinatumomab, and MTX as in Arm C. Patients also receive nivolumab IV over 30 minutes on days 11 and 25 of cycle 1 and days 1 and 15 of cycle 2. Treatment repeats every 36 days for 2 cycles in the absence of disease progression or unacceptable toxicity. NOTE: Patients with MRD \\\u003C 0.01% after cycle 1 may stop study treatment or may choose to continue to cycle 2. Patients with MRD \\>= 0.01% after cycle 1 proceed to cycle 2. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study. (CLOSED TO ACCRUAL 9\u002F19\u002F2024)",[13,14,15,16,18,20,21,22],{"label":40,"type":10,"description":41,"interventionNames":42},"Group 3, Arm E (dexamethasone, blinatumomab, MTX)","See Outline section",[43,44,13,14,15,16,45,17,18,19,20,46,21,47,48],"Radiation: 3-Dimensional Conformal Radiation Therapy","Drug: Asparaginase Erwinia chrysanthemi","Drug: Calaspargase Pegol","Drug: Mercaptopurine","Drug: Pegaspargase","Drug: Vincristine Sulfate",{"label":50,"type":10,"description":41,"interventionNames":51},"Group 3, Arm F (dexamethasone, blinatumomab, nivolumab)",[43,44,13,14,15,16,45,17,18,19,20,46,21,22,47,48],{"label":53,"type":10,"description":54,"interventionNames":55},"Group 4 Arm I (Dexamethasone, blinatumomab, nivolumab)","Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28, nivolumab IV, over 30 minutes on day 11 of cycle 1 and day 3 of cycle 2 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.",[13,14,15,16,45,17,18,19,20,21,22],{"label":57,"type":10,"description":58,"interventionNames":59},"Group 4, Arm H (dexamethasone blinatumomab)","Patients receive dexamethasone PO or IV on day 1 and 8 of cycle 1 only, blinatumomab IV via continuous infusion on days 1-28 and MTX IT on days 1 of cycle 1 only and days 15 and 36 ( for patients with CNS1\u002F2 at relapse only) or ITT on day 1 of cycle 1 only and days 15 and 36 (for patients with CNS 3 at relapse only) (day 1 IT therapy may be omitted from cycle 1 if intrathecal therapy is given with \\\u003C 7 days prior to the start of this cycle). Cycles repeat every 37 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo lumbar puncture, bone marrow biopsy and aspiration, and collection of blood, urine and cerebrospinal fluid throughout the study.",[13,14,15,16,17,18,19,20,21],[61,77,101,111,129,134,141,151,188,258,284,291,331,372,393,407],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"RADIATION","3-Dimensional Conformal Radiation Therapy","Undergo 3D-CRT",[40,50],[67,68,69,70,71,72,73,74,75,76],"3-dimensional radiation therapy","3D Conformal","3D CONFORMAL RADIATION THERAPY","3D CRT","3D radiotherapy","3D-CRT","Conformal Therapy","Radiation Conformal Therapy","Radiation, 3D Conformal","Three dimensional external beam radiation therapy (procedure)",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Asparaginase Erwinia chrysanthemi","Given IM",[40,50],[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"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":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"PROCEDURE","Biospecimen Collection","Undergo blood, urine and cerebrospinal fluid collection",[9,24,28,32,36,40,50,53,57],[107,108,109,110],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":112,"name":113,"description":114,"armGroupLabels":115,"otherNames":116},"BIOLOGICAL","Blinatumomab","Given IV",[9,24,28,32,36,40,50,53,57],[117,118,119,120,121,122,123,124,125,126,127,128],"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":102,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,24,28,32,36,40,50,53,57],null,{"type":102,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[9,24,28,32,36,40,50,53,57],[139,140],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":78,"name":142,"description":114,"armGroupLabels":143,"otherNames":144},"Calaspargase Pegol",[40,50,53],[145,146,147,148,149,150],"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":78,"name":152,"description":153,"armGroupLabels":154,"otherNames":155},"Cytarabine","Given IT",[9,24,28,40,50,53,57],[156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187],".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":78,"name":189,"description":190,"armGroupLabels":191,"otherNames":192},"Dexamethasone","Given PO or IV",[9,24,28,32,36,40,50,53,57],[193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257],"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":78,"name":259,"description":153,"armGroupLabels":260,"otherNames":261},"Hydrocortisone Sodium Succinate",[9,24,28,40,50,53,57],[262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283],"(11beta)-21-(3-Carboxy-1-oxopropyl)-11,17-dihydroxypregn-4-ene-3,20-dione, Monosodium Salt","A-Hydrocort","Buccalsone","Corlan","Cortisol Sodium Succinate","Cortop","Efcortelan","Emergent-EZ","Flebocortid","Hidroc Clora","Hycorace","Hydro-Adreson","Hydrocort","Hydrocortisone 21-Sodium Succinate","Hydrocortisone Na Succinate","Kinogen","Nordicort","Nositrol","Sinsurrene","Sodium hydrocortisone succinate","Solu-Cortef","Solu-Glyc",{"type":102,"name":285,"description":286,"armGroupLabels":287,"otherNames":288},"Lumbar Puncture","Undergo lumbar puncture",[9,24,28,32,36,40,50,53,57],[289,290],"LP","Spinal Tap",{"type":78,"name":292,"description":293,"armGroupLabels":294,"otherNames":295},"Mercaptopurine","Given PO",[40,50],[296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330],"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":78,"name":332,"description":333,"armGroupLabels":334,"otherNames":335},"Methotrexate","Given IT, PO, and IV",[9,24,28,32,36,40,50,53,57],[336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371],"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":112,"name":373,"description":114,"armGroupLabels":374,"otherNames":375},"Nivolumab",[9,28,36,50,53],[376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392],"ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo",{"type":78,"name":394,"description":395,"armGroupLabels":396,"otherNames":397},"Pegaspargase","Given IM or IV",[40,50],[398,399,400,401,402,403,404,405,406],"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":78,"name":408,"description":409,"armGroupLabels":410,"otherNames":411},"Vincristine Sulfate","Given IV push or via infusion",[40,50],[412,413,414,415,416,417,418,419],"Kyocristine","Leurocristine Sulfate","Leurocristine, sulfate","Oncovin","Vincasar","Vincosid","Vincrex","Vincristine, sulfate",[421],{"name":422,"affiliation":423,"role":424},"Stacy L Cooper","Children's Oncology Group","PRINCIPAL_INVESTIGATOR",[426,448,462,473,483,497,511,525,540,556,565,574,587,597,609,623,637,651,656,668,679,694,709,724,739,753,764,776,787,802,811,827,842,857,873,889,905,920,935,947,962,974,983,997,1002,1017,1032,1044,1058,1074,1089,1104,1120,1135,1146,1158,1172,1187,1202,1218,1232,1247,1262,1277,1283,1298,1313,1328,1340,1349,1359,1374,1383,1392,1405,1414,1423,1434,1439,1451,1456,1462,1471,1480,1488,1497,1511,1516,1525,1530,1539,1548,1557,1573,1584,1599,1615,1629,1641,1652,1667,1678,1688,1697,1702,1707,1713,1722,1728,1734,1740,1745,1750,1762,1768,1773,1781,1787,1793,1799,1805,1814,1826,1832,1838,1854,1869,1883,1897,1906,1921,1936,1951,1965,1980,1989,2002,2014,2025,2035,2044,2058,2072,2087,2103,2118,2132,2146,2161,2175,2191,2206,2221,2235,2241,2256,2270,2279,2294,2310,2324,2339,2351,2367,2382,2396,2411,2422,2437,2452,2468,2480,2489,2505,2520,2534,2545,2561,2576,2590,2602,2617,2632,2641,2652,2667,2678,2693,2705,2716,2731,2747,2763,2778,2793,2803,2812,2826,2841,2856,2868,2877,2887,2901,2910,2925,2934,2950,2965,2980,2987,2996,3010,3025,3039,3057,3072,3088,3104,3120,3136,3152,3164,3179,3194],{"facility":427,"status":428,"city":429,"state":430,"zip":431,"country":432,"countryCode":433,"cosmosGeoPoint":434,"geoPoint":439,"contacts":440},"Children's Hospital of Alabama","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":435,"coordinates":436},"Point",[437,438],-86.80249,33.52066,{"lat":438,"lon":437},[441,446],{"name":442,"role":443,"phone":444,"phoneExt":133,"email":445},"Site Public Contact","CONTACT","205-638-9285","oncologyresearch@peds.uab.edu",{"name":447,"role":424,"phone":133,"phoneExt":133,"email":133},"Matthew A. Kutny",{"facility":449,"status":428,"city":450,"state":430,"zip":451,"country":432,"countryCode":433,"cosmosGeoPoint":452,"geoPoint":456,"contacts":457},"USA Health Strada Patient Care Center","Mobile","36604",{"type":435,"coordinates":453},[454,455],-88.04305,30.69436,{"lat":455,"lon":454},[458,460],{"name":442,"role":443,"phone":459,"phoneExt":133,"email":133},"800-388-8721",{"name":461,"role":424,"phone":133,"phoneExt":133,"email":133},"Hamayun Imran",{"facility":463,"status":464,"city":465,"state":466,"zip":467,"country":432,"countryCode":433,"cosmosGeoPoint":468,"geoPoint":472,"contacts":133},"Providence Alaska Medical Center","SUSPENDED","Anchorage","Alaska","99508",{"type":435,"coordinates":469},[470,471],-149.90028,61.21806,{"lat":471,"lon":470},{"facility":474,"status":464,"city":475,"state":476,"zip":477,"country":432,"countryCode":433,"cosmosGeoPoint":478,"geoPoint":482,"contacts":133},"Kingman Regional Medical Center","Kingman","Arizona","86401",{"type":435,"coordinates":479},[480,481],-114.05301,35.18944,{"lat":481,"lon":480},{"facility":484,"status":428,"city":485,"state":476,"zip":486,"country":432,"countryCode":433,"cosmosGeoPoint":487,"geoPoint":491,"contacts":492},"Banner Children's at Desert","Mesa","85202",{"type":435,"coordinates":488},[489,490],-111.82264,33.42227,{"lat":490,"lon":489},[493,495],{"name":442,"role":443,"phone":494,"phoneExt":133,"email":133},"480-412-3100",{"name":496,"role":424,"phone":133,"phoneExt":133,"email":133},"Joseph C. 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Dulman",{"facility":2764,"status":428,"city":2765,"state":2750,"zip":2766,"country":432,"countryCode":433,"cosmosGeoPoint":2767,"geoPoint":2771,"contacts":2772},"Children's Hospital of The King's Daughters","Norfolk","23507",{"type":435,"coordinates":2768},[2769,2770],-76.28522,36.84681,{"lat":2770,"lon":2769},[2773,2776],{"name":442,"role":443,"phone":2774,"phoneExt":133,"email":2775},"757-668-7243","CCBDCresearch@chkd.org",{"name":2777,"role":424,"phone":133,"phoneExt":133,"email":133},"Melissa S. Mark",{"facility":2779,"status":428,"city":2780,"state":2750,"zip":2781,"country":432,"countryCode":433,"cosmosGeoPoint":2782,"geoPoint":2786,"contacts":2787},"VCU Massey Comprehensive Cancer Center","Richmond","23298",{"type":435,"coordinates":2783},[2784,2785],-77.46026,37.55376,{"lat":2785,"lon":2784},[2788,2791],{"name":442,"role":443,"phone":2789,"phoneExt":133,"email":2790},"804-628-6430","CTOclinops@vcu.edu",{"name":2792,"role":424,"phone":133,"phoneExt":133,"email":133},"Jordyn R. Griffin",{"facility":2794,"status":464,"city":2795,"state":2796,"zip":2797,"country":432,"countryCode":433,"cosmosGeoPoint":2798,"geoPoint":2802,"contacts":133},"Overlake Medical Center","Bellevue","Washington","98004",{"type":435,"coordinates":2799},[2800,2801],-122.20068,47.61038,{"lat":2801,"lon":2800},{"facility":2804,"status":464,"city":2805,"state":2796,"zip":2806,"country":432,"countryCode":433,"cosmosGeoPoint":2807,"geoPoint":2811,"contacts":133},"Valley Medical Center","Renton","98055",{"type":435,"coordinates":2808},[2809,2810],-122.21707,47.48288,{"lat":2810,"lon":2809},{"facility":2813,"status":428,"city":2814,"state":2796,"zip":2815,"country":432,"countryCode":433,"cosmosGeoPoint":2816,"geoPoint":2820,"contacts":2821},"Seattle Children's Hospital","Seattle","98105",{"type":435,"coordinates":2817},[2818,2819],-122.33207,47.60621,{"lat":2819,"lon":2818},[2822,2824],{"name":442,"role":443,"phone":2823,"phoneExt":133,"email":133},"866-987-2000",{"name":2825,"role":424,"phone":133,"phoneExt":133,"email":133},"Sarah E. Leary",{"facility":2827,"status":428,"city":2828,"state":2796,"zip":2829,"country":432,"countryCode":433,"cosmosGeoPoint":2830,"geoPoint":2834,"contacts":2835},"Providence Sacred Heart Medical Center and Children's Hospital","Spokane","99204",{"type":435,"coordinates":2831},[2832,2833],-117.42908,47.65966,{"lat":2833,"lon":2832},[2836,2839],{"name":442,"role":443,"phone":2837,"phoneExt":133,"email":2838},"800-228-6618","HopeBeginsHere@providence.org",{"name":2840,"role":424,"phone":133,"phoneExt":133,"email":133},"Judy L. Felgenhauer",{"facility":2842,"status":428,"city":2843,"state":2796,"zip":2844,"country":432,"countryCode":433,"cosmosGeoPoint":2845,"geoPoint":2849,"contacts":2850},"Mary Bridge Children's Hospital and Health Center","Tacoma","98405",{"type":435,"coordinates":2846},[2847,2848],-122.44429,47.25288,{"lat":2848,"lon":2847},[2851,2854],{"name":442,"role":443,"phone":2852,"phoneExt":133,"email":2853},"253-403-1461","research@multicare.org",{"name":2855,"role":424,"phone":133,"phoneExt":133,"email":133},"Robert G. Irwin",{"facility":2857,"status":428,"city":2843,"state":2796,"zip":2858,"country":432,"countryCode":433,"cosmosGeoPoint":2859,"geoPoint":2861,"contacts":2862},"Madigan Army Medical Center","98431",{"type":435,"coordinates":2860},[2847,2848],{"lat":2848,"lon":2847},[2863,2866],{"name":442,"role":443,"phone":2864,"phoneExt":133,"email":2865},"253-968-6144","melissa.a.forouhar.mil@health.mil",{"name":2867,"role":424,"phone":133,"phoneExt":133,"email":133},"Melissa A. Forouhar",{"facility":2869,"status":464,"city":2870,"state":2796,"zip":2871,"country":432,"countryCode":433,"cosmosGeoPoint":2872,"geoPoint":2876,"contacts":133},"North Star Lodge Cancer Center at Yakima Valley Memorial Hospital","Yakima","98902",{"type":435,"coordinates":2873},[2874,2875],-120.5059,46.60207,{"lat":2875,"lon":2874},{"facility":2878,"status":464,"city":2879,"state":2880,"zip":2881,"country":432,"countryCode":433,"cosmosGeoPoint":2882,"geoPoint":2886,"contacts":133},"United Hospital Center","Bridgeport","West Virginia","26330",{"type":435,"coordinates":2883},[2884,2885],-80.2562,39.28648,{"lat":2885,"lon":2884},{"facility":2888,"status":428,"city":2889,"state":2880,"zip":2890,"country":432,"countryCode":433,"cosmosGeoPoint":2891,"geoPoint":2895,"contacts":2896},"West Virginia University Charleston Division","Charleston","25304",{"type":435,"coordinates":2892},[2893,2894],-81.63262,38.34982,{"lat":2894,"lon":2893},[2897,2899],{"name":442,"role":443,"phone":2898,"phoneExt":133,"email":133},"304-388-9944",{"name":2900,"role":424,"phone":133,"phoneExt":133,"email":133},"Mohamad H. Badawi",{"facility":2902,"status":464,"city":2903,"state":2880,"zip":2904,"country":432,"countryCode":433,"cosmosGeoPoint":2905,"geoPoint":2909,"contacts":133},"WVUH-Berkely Medical Center","Martinsburg","25401",{"type":435,"coordinates":2906},[2907,2908],-77.96389,39.45621,{"lat":2908,"lon":2907},{"facility":2911,"status":428,"city":2912,"state":2880,"zip":2913,"country":432,"countryCode":433,"cosmosGeoPoint":2914,"geoPoint":2918,"contacts":2919},"West Virginia University Healthcare","Morgantown","26506",{"type":435,"coordinates":2915},[2916,2917],-79.9559,39.62953,{"lat":2917,"lon":2916},[2920,2923],{"name":442,"role":443,"phone":2921,"phoneExt":133,"email":2922},"304-293-7374","cancertrialsinfo@hsc.wvu.edu",{"name":2924,"role":424,"phone":133,"phoneExt":133,"email":133},"Ashley E. Meyer",{"facility":2926,"status":464,"city":2927,"state":2880,"zip":2928,"country":432,"countryCode":433,"cosmosGeoPoint":2929,"geoPoint":2933,"contacts":133},"Camden Clark Medical Center","Parkersburg","26101",{"type":435,"coordinates":2930},[2931,2932],-81.56151,39.26674,{"lat":2932,"lon":2931},{"facility":2935,"status":428,"city":2936,"state":2937,"zip":2938,"country":432,"countryCode":433,"cosmosGeoPoint":2939,"geoPoint":2943,"contacts":2944},"Saint Vincent Hospital Cancer Center Green Bay","Green Bay","Wisconsin","54301",{"type":435,"coordinates":2940},[2941,2942],-88.01983,44.51916,{"lat":2942,"lon":2941},[2945,2948],{"name":442,"role":443,"phone":2946,"phoneExt":133,"email":2947},"920-433-8889","WI_research_admin@hshs.org",{"name":2949,"role":424,"phone":133,"phoneExt":133,"email":133},"Catherine A. Long",{"facility":2951,"status":428,"city":2952,"state":2937,"zip":2953,"country":432,"countryCode":433,"cosmosGeoPoint":2954,"geoPoint":2958,"contacts":2959},"University of Wisconsin Carbone Cancer Center - University Hospital","Madison","53792",{"type":435,"coordinates":2955},[2956,2957],-89.40123,43.07305,{"lat":2957,"lon":2956},[2960,2963],{"name":442,"role":443,"phone":2961,"phoneExt":133,"email":2962},"800-622-8922","clinicaltrials@cancer.wisc.edu",{"name":2964,"role":424,"phone":133,"phoneExt":133,"email":133},"Cathy A. Lee-Miller",{"facility":2966,"status":428,"city":2967,"state":2937,"zip":2968,"country":432,"countryCode":433,"cosmosGeoPoint":2969,"geoPoint":2973,"contacts":2974},"Children's Hospital of Wisconsin","Milwaukee","53226",{"type":435,"coordinates":2970},[2971,2972],-87.90647,43.0389,{"lat":2972,"lon":2971},[2975,2978],{"name":442,"role":443,"phone":2976,"phoneExt":133,"email":2977},"414-955-4727","MACCCTO@mcw.edu",{"name":2979,"role":424,"phone":133,"phoneExt":133,"email":133},"Michael J. Burke",{"facility":2981,"status":464,"city":2982,"state":2983,"zip":2984,"country":2985,"countryCode":2986,"cosmosGeoPoint":133,"geoPoint":133,"contacts":133},"John Hunter Children's Hospital","Hunter Regional Mail Centre","New South Wales","2310","Australia","AU",{"facility":2988,"status":464,"city":2989,"state":2983,"zip":2990,"country":2985,"countryCode":2986,"cosmosGeoPoint":2991,"geoPoint":2995,"contacts":133},"Sydney Children's Hospital","Randwick","2031",{"type":435,"coordinates":2992},[2993,2994],151.24895,-33.91439,{"lat":2994,"lon":2993},{"facility":2997,"status":428,"city":2998,"state":2983,"zip":2999,"country":2985,"countryCode":2986,"cosmosGeoPoint":3000,"geoPoint":3004,"contacts":3005},"The Children's Hospital at Westmead","Westmead","2145",{"type":435,"coordinates":3001},[3002,3003],150.98768,-33.80383,{"lat":3003,"lon":3002},[3006,3008],{"name":442,"role":443,"phone":3007,"phoneExt":133,"email":133},"61-2-9845 1400",{"name":3009,"role":424,"phone":133,"phoneExt":133,"email":133},"Bhavna Padhye",{"facility":3011,"status":428,"city":3012,"state":3013,"zip":3014,"country":2985,"countryCode":2986,"cosmosGeoPoint":3015,"geoPoint":3019,"contacts":3020},"Queensland Children's Hospital","South Brisbane","Queensland","4101",{"type":435,"coordinates":3016},[3017,3018],153.02049,-27.48034,{"lat":3018,"lon":3017},[3021,3023],{"name":442,"role":443,"phone":3022,"phoneExt":133,"email":133},"61 7 3068 1111",{"name":3024,"role":424,"phone":133,"phoneExt":133,"email":133},"Christopher J. Fraser",{"facility":3026,"status":428,"city":3027,"state":3028,"zip":3029,"country":2985,"countryCode":2986,"cosmosGeoPoint":3030,"geoPoint":3034,"contacts":3035},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":435,"coordinates":3031},[3032,3033],115.8614,-31.95224,{"lat":3033,"lon":3032},[3036,3037],{"name":442,"role":443,"phone":133,"phoneExt":133,"email":994},{"name":3038,"role":424,"phone":133,"phoneExt":133,"email":133},"Michelle Ng",{"facility":3040,"status":428,"city":3041,"state":3042,"zip":3043,"country":3044,"countryCode":3045,"cosmosGeoPoint":3046,"geoPoint":3050,"contacts":3051},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":435,"coordinates":3047},[3048,3049],-114.08529,51.05011,{"lat":3049,"lon":3048},[3052,3055],{"name":442,"role":443,"phone":3053,"phoneExt":133,"email":3054},"403-220-6898","research4kids@ucalgary.ca",{"name":3056,"role":424,"phone":133,"phoneExt":133,"email":133},"Victor A. Lewis",{"facility":3058,"status":428,"city":3059,"state":3042,"zip":3060,"country":3044,"countryCode":3045,"cosmosGeoPoint":3061,"geoPoint":3065,"contacts":3066},"University of Alberta Hospital","Edmonton","T6G 2B7",{"type":435,"coordinates":3062},[3063,3064],-113.46871,53.55014,{"lat":3064,"lon":3063},[3067,3070],{"name":442,"role":443,"phone":3068,"phoneExt":133,"email":3069},"780-407-8798","pedsoncologyresearch@ahs.ca",{"name":3071,"role":424,"phone":133,"phoneExt":133,"email":133},"Sarah J. McKillop",{"facility":3073,"status":428,"city":3074,"state":3075,"zip":3076,"country":3044,"countryCode":3045,"cosmosGeoPoint":3077,"geoPoint":3081,"contacts":3082},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"type":435,"coordinates":3078},[3079,3080],-123.11934,49.24966,{"lat":3080,"lon":3079},[3083,3086],{"name":442,"role":443,"phone":3084,"phoneExt":3085,"email":133},"604-875-2345","6477",{"name":3087,"role":424,"phone":133,"phoneExt":133,"email":133},"Rebecca J. Deyell",{"facility":3089,"status":428,"city":3090,"state":3091,"zip":3092,"country":3044,"countryCode":3045,"cosmosGeoPoint":3093,"geoPoint":3097,"contacts":3098},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":435,"coordinates":3094},[3095,3096],-97.14704,49.8844,{"lat":3096,"lon":3095},[3099,3102],{"name":442,"role":443,"phone":3100,"phoneExt":133,"email":3101},"866-561-1026","ctu_web@cancercare.mb.ca",{"name":3103,"role":424,"phone":133,"phoneExt":133,"email":133},"Stephanie M. Villeneuve",{"facility":3105,"status":428,"city":3106,"state":3107,"zip":3108,"country":3044,"countryCode":3045,"cosmosGeoPoint":3109,"geoPoint":3113,"contacts":3114},"Janeway Child Health Centre","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":435,"coordinates":3110},[3111,3112],-52.70931,47.56494,{"lat":3112,"lon":3111},[3115,3118],{"name":442,"role":443,"phone":3116,"phoneExt":133,"email":3117},"709-777-8727","beverlyj.mitchell@easternhealth.ca",{"name":3119,"role":424,"phone":133,"phoneExt":133,"email":133},"Lisa A. Goodyear",{"facility":3121,"status":428,"city":3122,"state":3123,"zip":3124,"country":3044,"countryCode":3045,"cosmosGeoPoint":3125,"geoPoint":3129,"contacts":3130},"IWK Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":435,"coordinates":3126},[3127,3128],-63.57688,44.64269,{"lat":3128,"lon":3127},[3131,3134],{"name":442,"role":443,"phone":3132,"phoneExt":133,"email":3133},"902-470-8520","Research@iwk.nshealth.ca",{"name":3135,"role":424,"phone":133,"phoneExt":133,"email":133},"Chelsea Ash",{"facility":3137,"status":428,"city":3138,"state":3139,"zip":3140,"country":3044,"countryCode":3045,"cosmosGeoPoint":3141,"geoPoint":3145,"contacts":3146},"The Montreal Children's Hospital of the MUHC","Montreal","Quebec","H3H 1P3",{"type":435,"coordinates":3142},[3143,3144],-73.58781,45.50884,{"lat":3144,"lon":3143},[3147,3150],{"name":442,"role":443,"phone":3148,"phoneExt":133,"email":3149},"514-412-4445","info@thechildren.com",{"name":3151,"role":424,"phone":133,"phoneExt":133,"email":133},"Stephanie Mourad",{"facility":3153,"status":428,"city":3138,"state":3139,"zip":3154,"country":3044,"countryCode":3045,"cosmosGeoPoint":3155,"geoPoint":3157,"contacts":3158},"Centre Hospitalier Universitaire Sainte-Justine","H3T 1C5",{"type":435,"coordinates":3156},[3143,3144],{"lat":3144,"lon":3143},[3159,3162],{"name":442,"role":443,"phone":3160,"phoneExt":133,"email":3161},"514-345-4931","yvan.samson@umontreal.ca",{"name":3163,"role":424,"phone":133,"phoneExt":133,"email":133},"Monia Marzouki",{"facility":3165,"status":428,"city":3166,"state":3139,"zip":3167,"country":3044,"countryCode":3045,"cosmosGeoPoint":3168,"geoPoint":3172,"contacts":3173},"Centre Hospitalier Universitaire de Sherbrooke-Fleurimont","Sherbrooke","J1H 5N4",{"type":435,"coordinates":3169},[3170,3171],-71.89908,45.40008,{"lat":3171,"lon":3170},[3174,3177],{"name":442,"role":443,"phone":3175,"phoneExt":133,"email":3176},"819-820-6480","crcinformation.chus@ssss.gouv.qc.ca",{"name":3178,"role":424,"phone":133,"phoneExt":133,"email":133},"Josee Brossard",{"facility":3180,"status":428,"city":3181,"state":133,"zip":3182,"country":3044,"countryCode":3045,"cosmosGeoPoint":3183,"geoPoint":3187,"contacts":3188},"CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)","Québec","G1V 4G2",{"type":435,"coordinates":3184},[3185,3186],-71.21454,46.81228,{"lat":3186,"lon":3185},[3189,3192],{"name":442,"role":443,"phone":3190,"phoneExt":133,"email":3191},"418-525-4444","rechclinique@crchudequebec.ulaval.ca",{"name":3193,"role":424,"phone":133,"phoneExt":133,"email":133},"Bruno Michon",{"facility":3195,"status":428,"city":3196,"state":133,"zip":3197,"country":3198,"countryCode":3199,"cosmosGeoPoint":3200,"geoPoint":3204,"contacts":3205},"University Pediatric Hospital","San Juan","00926","Puerto Rico","PR",{"type":435,"coordinates":3201},[3202,3203],-66.10572,18.46633,{"lat":3203,"lon":3202},[3206,3208],{"name":442,"role":443,"phone":3207,"phoneExt":133,"email":133},"787-474-0333",{"name":3209,"role":424,"phone":133,"phoneExt":133,"email":133},"Maria E. Echevarria",{"type":3211,"investigatorFullName":133,"investigatorTitle":133,"investigatorAffiliation":133,"oldNameTitle":133,"oldOrganization":133},"SPONSOR","100404441","phase-2-a-study-to-compare-blinatumomab-alone-to-blinatumomab-with-nivolumab-in-patients-diagnosed-with-first-relapse-b-cell-acute-lymphoblastic-leukemia-b-all-100404441",false,"NCT04546399","A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >\u002F= 1 to \u003C 31 Years Old With First Relapse","Inclusion Criteria:\n\n* Patients must be \\>= 1 and \\\u003C 31 years at time of enrollment\n* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:\n\n  * Isolated bone marrow relapse\n  * Isolated central nervous system (CNS) (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n  * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testes\n* Patients with Down syndrome (DS) are eligible in the following categories:\n\n  * Isolated bone marrow relapse\n  * Combined bone marrow with CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n\n  * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression\n  * Patients must not have had a prior hematopoietic stem cell transplant\n  * A single intrathecal chemotherapy at the time of relapse will be allowed. If \\\u003C 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted\n  * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and\u002For hydroxyurea only) is permissible\n\n    * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \\>= 30,000\u002Ful at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no \"washout\" is required\n    * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \\\u003C 30,000\u002Ful at the time of enrollment must be given a 24 hour \"washout\" before starting immunotherapy\n  * Note: There is no waiting period or \"washout\" for patients who relapse while receiving upfront therapy\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (within 7 calendar days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n    * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: 1.7 (male), 1.4 (female)\n\n      * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\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\n\nExclusion Criteria:\n\n* Patients with B-lymphoblastic lymphoma (B-LLy)\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)\n* Patients with mixed phenotype acute leukemia (MPAL)\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 with active, uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment\n  * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.\n  * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \\> 48 hours\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\n  * Active viral or protozoal infection requiring IV treatment\n* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.\n* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* Patients with an active known\u002Fsuspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Patients with DS patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are not eligible\n\n  * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab\n* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose","ALL","1 Year","30 Years",{"count":3223,"type":3224},461,"ESTIMATED","INTERVENTIONAL",[3227],"PHASE2","This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.",[3230,3231],"Down Syndrome","Recurrent B Acute Lymphoblastic Leukemia","2026-06-11",{"date":3234,"type":3235},"2026-06-12","ACTUAL",{"date":3237,"type":3235},"2020-12-17",{"date":3239,"type":3224},"2028-06-30",{"name":5,"class":6},225]