[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598522":3},{"organization":4,"armGroups":7,"interventions":54,"overallOfficials":708,"centralContacts":77,"locations":77,"responsibleParty":712,"collaborators":77,"id":714,"slug":77,"hasResults":715,"nctId":716,"briefTitle":717,"officialTitle":718,"acronym":77,"eligibilityCriteria":719,"healthyVolunteers":715,"sex":720,"minAge":721,"maxAge":722,"enrollmentInfo":723,"targetDuration":77,"studyType":726,"phases":727,"briefSummary":730,"conditions":731,"keywords":77,"overallStatus":737,"whyStopped":77,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":77},{"fullName":5,"class":6},"Children's Oncology Group","NETWORK",[8,39,44,51],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I, Arm A (T-ALL, no daratumumab)","ACTIVE_COMPARATOR","See Detailed Description",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Procedure: Biopsy Procedure","Procedure: Biospecimen Collection","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Drug: Calaspargase Pegol","Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Daunorubicin Hydrochloride","Drug: Dexamethasone","Drug: Doxorubicin Hydrochloride","Procedure: Echocardiography Test","Procedure: Lumbar Puncture","Procedure: Magnetic Resonance Imaging","Drug: Mercaptopurine Oral Suspension","Drug: Methotrexate","Drug: Methylprednisolone","Drug: Nelarabine","Drug: Pegaspargase","Drug: Prednisolone","Drug: Prednisone","Other: Questionnaire Administration","Radiation: Radiation Therapy","Drug: Therapeutic Hydrocortisone","Drug: Thioguanine","Procedure: Ultrasound Imaging","Drug: Vincristine Sulfate",{"label":40,"type":41,"description":11,"interventionNames":42},"Group I, Arm B (T-ALL, daratumumab)","EXPERIMENTAL",[13,14,15,16,17,18,19,43,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38],"Biological: Daratumumab",{"label":45,"type":10,"description":11,"interventionNames":46},"Group II, Arm C (T-LL, no daratumumab)",[13,14,15,16,47,48,17,49,18,19,20,21,22,23,24,25,26,27,28,30,50,31,32,33,34,35,36,37,38],"Procedure: Bone Scan","Drug: Bortezomib","Procedure: Computed Tomography","Procedure: Positron Emission Tomography",{"label":52,"type":41,"description":11,"interventionNames":53},"Group II, Arm D (T-LL, daratumumab)",[13,14,15,16,47,48,17,49,18,19,43,20,21,22,23,24,25,26,27,28,30,50,31,32,33,34,35,36,37,38],[55,64,73,78,85,91,108,119,136,181,218,231,250,320,349,356,363,383,391,432,466,475,489,501,558,604,609,627,655,683,696],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[9,40,45,52],[61,62,63],"Biopsy","BIOPSY_TYPE","Bx",{"type":56,"name":65,"description":66,"armGroupLabels":67,"otherNames":68},"Biospecimen Collection","Undergo blood sample collection",[9,40,45,52],[69,70,71,72],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":56,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,40,45,52],null,{"type":56,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[9,40,45,52],[83,84],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":56,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"Bone Scan","Undergo bone scan",[45,52],[90],"Bone Scintigraphy",{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"DRUG","Bortezomib","Given IV or SC",[45,52],[97,98,99,100,101,102,103,104,105,106,107],"[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid","LDP 341","LDP-341","LDP341","MLN 341","MLN-341","MLN341","PS 341","PS-341","PS341","Velcade",{"type":92,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"Calaspargase Pegol","Given IV",[9,40,45,52],[113,114,115,116,117,118],"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":56,"name":120,"description":121,"armGroupLabels":122,"otherNames":123},"Computed Tomography","Undergo CT",[45,52],[124,125,126,127,128,129,130,131,132,133,134,135],"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":92,"name":137,"description":110,"armGroupLabels":138,"otherNames":139},"Cyclophosphamide",[9,40,45,52],[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180],"(-)-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":92,"name":182,"description":183,"armGroupLabels":184,"otherNames":185},"Cytarabine","Given IT or IV or SC",[9,40,45,52],[186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217],".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":219,"name":220,"description":110,"armGroupLabels":221,"otherNames":222},"BIOLOGICAL","Daratumumab",[40,52],[223,224,225,226,227,228,229,230],"Daratumumab Biosimilar HLX15","Daratumumab-fihj","Darzalex","HLX15","HuMax-CD38","JNJ 54767414","JNJ-54767414","JNJ54767414",{"type":92,"name":232,"description":110,"armGroupLabels":233,"otherNames":234},"Daunorubicin Hydrochloride",[9,40,45,52],[235,236,237,238,239,240,241,242,243,244,245,246,247,248,249],"Cerubidin","Cerubidine","Cloridrato de Daunorubicina","Daunoblastin","Daunoblastina","Daunoblastine","Daunomycin Hydrochloride","Daunomycin, hydrochloride","Daunorubicin.HCl","Daunorubicini Hydrochloridum","FI-6339","Ondena","RP-13057","Rubidomycin Hydrochloride","Rubilem",{"type":92,"name":251,"description":252,"armGroupLabels":253,"otherNames":254},"Dexamethasone","Given PO or IV",[9,40,45,52],[255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319],"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":92,"name":321,"description":110,"armGroupLabels":322,"otherNames":323},"Doxorubicin Hydrochloride",[9,40,45,52],[324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348],"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":56,"name":350,"description":351,"armGroupLabels":352,"otherNames":353},"Echocardiography Test","Undergo ECHO",[9,40,45,52],[354,355],"EC","Echocardiography",{"type":56,"name":357,"description":358,"armGroupLabels":359,"otherNames":360},"Lumbar Puncture","Under lumbar puncture",[9,40,45,52],[361,362],"LP","Spinal Tap",{"type":56,"name":364,"description":365,"armGroupLabels":366,"otherNames":367},"Magnetic Resonance Imaging","Undergo MRI",[9,40,45,52],[368,369,370,371,372,373,374,375,376,377,378,379,380,381,382],"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":92,"name":384,"description":385,"armGroupLabels":386,"otherNames":387},"Mercaptopurine Oral Suspension","Given PO",[9,40,45,52],[388,389,390],"6-MP Oral Suspension","Purixan","Xaluprine",{"type":92,"name":392,"description":393,"armGroupLabels":394,"otherNames":395},"Methotrexate","Given IT or IV or PO",[9,40,45,52],[396,397,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431],"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":92,"name":433,"description":110,"armGroupLabels":434,"otherNames":435},"Methylprednisolone",[9,40,45,52],[436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453,454,455,456,457,458,459,460,461,462,463,464,465],"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":92,"name":467,"description":110,"armGroupLabels":468,"otherNames":469},"Nelarabine",[9,40],[470,471,472,473,474],"2-Amino-6-methoxypurine arabinoside","506U78","Arranon","Compound 506U78","GW506U78",{"type":92,"name":476,"description":477,"armGroupLabels":478,"otherNames":479},"Pegaspargase","Given IV or IM",[9,40,45,52],[480,481,482,483,484,485,486,487,488],"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":56,"name":490,"description":491,"armGroupLabels":492,"otherNames":493},"Positron Emission Tomography","Undergo PET or PET-CT",[45,52],[494,495,496,497,498,499,500],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":92,"name":502,"description":252,"armGroupLabels":503,"otherNames":504},"Prednisolone",[9,40,45,52],[505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520,521,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539,540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557],"(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":92,"name":559,"description":252,"armGroupLabels":560,"otherNames":561},"Prednisone",[9,40,45,52],[562,563,564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,585,586,587,588,589,590,591,592,593,594,595,596,597,598,599,600,601,602,603],".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":605,"name":606,"description":607,"armGroupLabels":608,"otherNames":77},"OTHER","Questionnaire Administration","Ancillary studies",[9,40,45,52],{"type":610,"name":611,"description":612,"armGroupLabels":613,"otherNames":614},"RADIATION","Radiation Therapy","Undergo radiation therapy",[9,40,45,52],[615,616,617,618,619,620,621,622,623,624,625,626],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",{"type":92,"name":628,"description":629,"armGroupLabels":630,"otherNames":631},"Therapeutic Hydrocortisone","Given IT",[9,40,45,52],[632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654],"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":92,"name":656,"description":385,"armGroupLabels":657,"otherNames":658},"Thioguanine",[9,40,45,52],[659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682],"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":56,"name":684,"description":685,"armGroupLabels":686,"otherNames":687},"Ultrasound Imaging","Undergo ultrasound",[9,40,45,52],[688,689,690,691,692,693,694,695],"2-Dimensional Grayscale Ultrasound Imaging","2-Dimensional Ultrasound Imaging","2D-US","Ultrasonography","Ultrasound","Ultrasound Test","Ultrasound, Medical","US",{"type":92,"name":697,"description":110,"armGroupLabels":698,"otherNames":699},"Vincristine Sulfate",[9,40,45,52],[700,701,702,703,704,705,706,707],"Kyocristine","Leurocristine Sulfate","Leurocristine, sulfate","Oncovin","Vincasar","Vincosid","Vincrex","Vincristine, sulfate",[709],{"name":710,"affiliation":5,"role":711},"Keith J August","PRINCIPAL_INVESTIGATOR",{"type":713,"investigatorFullName":77,"investigatorTitle":77,"investigatorAffiliation":77,"oldNameTitle":77,"oldOrganization":77},"SPONSOR","100598522",false,"NCT07072585","Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL)","A Phase 2\u002F3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)","Inclusion Criteria:\n\n* All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrolled on AALL2331.\n* Patients must be \\> 365 days and \\\u003C 21 years of age at the time of diagnosis.\n* \\* Newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-lineage lymphoblastic lymphoma (T-LL) stages II-IV.\n\n  * Note: A diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (CD19\u002FCD22\u002FCD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a, and are present either in peripheral blood or \\> 25% in the bone marrow. If surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including TdT, CD34 or CD99 will be assessed for expression. Cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory.\n  * For T-LL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL. For tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LL defined by the submitting institution will be accepted.\n\nExclusion Criteria:\n\n* Diagnosis of Down syndrome (trisomy 21).\n* Patients with known Charcot-Marie-Tooth disease.\n* \\* Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of T-ALL, T-LL or for any cancer diagnosis prior to the initiation of protocol therapy on AALL2331 with the exception of:\n\n  * Steroid pretreatment: Prednisone or methylprednisolone for ≤ 120 hours (5 days) in the 7 days prior to initiating induction chemotherapy or for ≤ 336 hours (14 days) in the 28 days prior to initiation of protocol therapy does not affect eligibility.\n  * Intrathecal cytarabine; or\n  * Pretreatment with hydroxyurea; or\n  * 600 cGy of chest irradiation, if medically necessary.\n  * Pre-treatment 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 sedation to prevent or treat airway edema. Patients who receive a single dose of dexamethasone to prevent or treat airway edema in the 28 days preceding diagnosis are eligible for this study.\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\n  * Lactating females who plan to breastfeed their infants.\n* Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.\n* Known severe persistent asthma anytime in the previous two years or uncontrolled asthma of any classification.\n* Peripheral neurotoxicity: Pre-existing ≥ grade 2 sensory or motor peripheral neurotoxicity.\n* Seizure disorder: Patients must not have an uncontrolled seizure disorder. Patients with a seizure history or a controlled seizure disorder are eligible. A controlled seizure disorder is defined as having stable or decreasing symptoms over the past 3 months without anti-epileptic medications or is on a stable or decreasing dose of anti-epileptic medication.\n* \\* Patients who are previously known to be seropositive for HIV except for HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment on this trial.\n\n  * Patients with evidence of chronic hepatitis B (HBV) infection, except for patients who have an HBV viral load that is undetectable on suppressive therapy.\n  * Patients with a history of hepatitis C virus (HCV) infection, except for those patients who have been treated and cured, or patients who are currently on HCV treatment who have an undetectable HCV viral load.\n* Patients with significant hepatic dysfunction defined as those with an alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\> 10x upper limit of normal (ULN) or direct bilirubin \\> 2x ULN unless the patient has known Gilbert's syndrome or has 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 National Cancer Institute (NCI) requirements for human studies must be met.","ALL","365 Days","21 Years",{"count":724,"type":725},1708,"ESTIMATED","INTERVENTIONAL",[728,729],"PHASE2","PHASE3","This phase II\u002FIII trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. 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. Giving chemotherapy with daratumumab may kill more cancer cells.",[732,733,734,735,736],"Stage II T Lymphoblastic Leukemia\u002FLymphoma","Stage III T Lymphoblastic Leukemia\u002FLymphoma","Stage IV T Lymphoblastic Leukemia\u002FLymphoma","T Acute Lymphoblastic Leukemia","T Lymphoblastic Lymphoma","NOT_YET_RECRUITING","2026-06-15",{"date":740,"type":741},"2026-06-17","ACTUAL",{"date":743,"type":725},"2026-08-28",{"date":745,"type":725},"2035-09-01",{"name":5,"class":6}]