[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100296220":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":242,"centralContacts":246,"locations":247,"responsibleParty":268,"collaborators":270,"id":274,"slug":275,"hasResults":276,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":246,"eligibilityCriteria":280,"healthyVolunteers":276,"sex":281,"minAge":282,"maxAge":246,"enrollmentInfo":283,"targetDuration":246,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":246,"overallStatus":250,"whyStopped":246,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (combination chemotherapy)","EXPERIMENTAL","See detailed description",[13,14,15,16,17,18,19,20,21],"Drug: Bortezomib","Drug: Clofarabine","Drug: Cyclophosphamide","Drug: Dexamethasone","Drug: Etoposide","Biological: Ofatumumab","Biological: Pegfilgrastim","Biological: Rituximab","Drug: Vincristine Sulfate Liposome",[23,35,42,80,149,163,173,200,237],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Bortezomib","Given SC",[9],[29,30,31,32,33,34],"[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid","LDP 341","MLN341","PS-341","PS341","Velcade",{"type":24,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Clofarabine","Given IV",[9],[40,41],"Clofarex","Clolar",{"type":24,"name":43,"description":37,"armGroupLabels":44,"otherNames":45},"Cyclophosphamide",[9],[46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","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",{"type":24,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Dexamethasone","Given IV or PO",[9],[85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148],"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","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex",{"type":24,"name":150,"description":37,"armGroupLabels":151,"otherNames":152},"Etoposide",[9],[153,154,155,156,157,158,159,160,161,162],"Demethyl Epipodophyllotoxin Ethylidine Glucoside","EPEG","Lastet","Toposar","Vepesid","VP 16","VP 16-213","VP-16","VP-16-213","VP16",{"type":164,"name":165,"description":37,"armGroupLabels":166,"otherNames":167},"BIOLOGICAL","Ofatumumab",[9],[168,169,170,171,172],"Arzerra","GSK1841157","HuMax-CD20","HuMax-CD20, 2F2","Kesimpta",{"type":164,"name":174,"description":26,"armGroupLabels":175,"otherNames":176},"Pegfilgrastim",[9],[177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199],"Filgrastim SD-01","filgrastim-SD\u002F01","Fulphila","HSP-130","Jinyouli","Neulasta","Neulastim","Nyvepria","PEG-filgrastim","Pegcyte","Pegfilgrastim Biosimilar HSP-130","Pegfilgrastim Biosimilar Nyvepria","Pegfilgrastim Biosimilar Pegcyte","Pegfilgrastim Biosimilar Udenyca","Pegfilgrastim Biosimilar Ziextenzo","pegfilgrastim-apgf","pegfilgrastim-bmez","pegfilgrastim-cbqv","Pegfilgrastim-jmdb","SD-01","SD-01 sustained duration G-CSF","Udenyca","Ziextenzo",{"type":164,"name":201,"description":37,"armGroupLabels":202,"otherNames":203},"Rituximab",[9],[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],"ABP 798","BI 695500","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT-P10","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","MabThera","Monoclonal Antibody IDEC-C2B8","PF-05280586","Riabni","Rituxan","Rituximab ABBS","Rituximab ARRX","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","Rituximab Biosimilar SIBP-02","rituximab biosimilar TQB2303","Rituximab PVVR","rituximab-abbs","Rituximab-arrx","Rituximab-pvvr","RTXM83","Ruxience","Truxima",{"type":24,"name":238,"description":37,"armGroupLabels":239,"otherNames":240},"Vincristine Sulfate Liposome",[9],[241],"Marqibo",[243],{"name":244,"affiliation":5,"role":245},"Maro Ohanian","PRINCIPAL_INVESTIGATOR",null,[248],{"facility":249,"status":250,"city":251,"state":252,"zip":253,"country":254,"countryCode":255,"cosmosGeoPoint":256,"geoPoint":261,"contacts":262},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":257,"coordinates":258},"Point",[259,260],-95.36327,29.76328,{"lat":260,"lon":259},[263,267],{"name":244,"role":264,"phone":265,"phoneExt":246,"email":266},"CONTACT","713-745-0394","MOhanian@mdanderson.org",{"name":244,"role":245,"phone":246,"phoneExt":246,"email":246},{"type":269,"investigatorFullName":246,"investigatorTitle":246,"investigatorAffiliation":246,"oldNameTitle":246,"oldOrganization":246},"SPONSOR",[271],{"name":272,"class":273},"National Cancer Institute (NCI)","NIH","100296220","phase-2-combination-chemotherapy-in-treating-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukemia-lymphoblastic-lymphoma-burkitt-lymphomaleukemia-or-double-hit-lymphomaleukemia-100296220",false,"NCT03136146","Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma\u002FLeukemia, or Double-Hit Lymphoma\u002FLeukemia","Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)","Inclusion Criteria:\n\n* Relapsed\u002Frefractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):\n\n  * Relapsed and\u002For refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)\n  * Relapsed and\u002For refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia\u002Flymphoma or \"double-hit\" leukemia\u002Flymphoma (phase II only)\n* At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset\n* Age older than 15 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3 (There may be certain patients with performance status \\[PS\\] 3 in the context of rapidly proliferative\u002Frefractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)\n* Serum bilirubin =\\\u003C 1.5 mg\u002FdL\n* Serum glutamate pyruvate transaminase (SGPT) =\\\u003C 3 x upper limit normal (ULN), with exception for Gilbert's syndrome\n* Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL\u002Fmin\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active \\>= grade 3 peripheral neuropathy\n* Active hepatic graft-versus-host disease\n* Known positivity for hepatitis B or C\n* Pregnancy\n* Breast feeding","ALL","15 Years",{"count":284,"type":285},42,"ESTIMATED","INTERVENTIONAL",[288],"PHASE2","This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma\u002Fleukemia, or double-hit lymphoma\u002Fleukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[291,292,293,294,295,296,297,298,299,300,301],"Recurrent Acute Lymphoblastic Leukemia","Recurrent Adult Lymphoblastic Lymphoma","Recurrent Burkitt Leukemia","Recurrent Burkitt Lymphoma","Recurrent Childhood Lymphoblastic Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Acute Lymphoblastic Leukemia","Refractory Burkitt Leukemia","Refractory Burkitt Lymphoma","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Lymphoblastic Lymphoma","2026-02-12",{"date":304,"type":305},"2026-02-17","ACTUAL",{"date":307,"type":305},"2017-08-09",{"date":309,"type":285},"2027-08-01",{"name":5,"class":6},1]