{"entity":{"id":"nct02883049","kind":"trial","name":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations","aka":[],"tldr":"A phase 3 trial of Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin, Dexamethasone, Doxorubicin, Etoposide, Leucovorin, Mercaptopurine, Methotrexate, Asparaginase, Prednisone, Thioguanine and Vincristine in Acute lymphoblastic leukaemia and Leukaemia, run by National Cancer Institute (NCI), completed.","summary":"Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations is a phase 3 interventional study registered as NCT02883049 by National Cancer Institute (NCI), with 5949 participants recorded, started 2012-02-29 and reaching its primary completion in 2022-12-31. Interventions recorded: Clofarabine, Cyclophosphamide, Cytarabine, Dasatinib, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Etoposide, Hydrocortisone Sodium Succinate, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate. Conditions recorded: B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia, BCR-ABL1-Like, Central Nervous System Leukemia, Testicular Leukemia.\n\nLinked to the drug Clofarabine because the registry names it among its interventions and Acute lymphoblastic leukaemia and Leukaemia among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT02883049","url":"https://clinicaltrials.gov/study/NCT02883049"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["all-leukemia","leukaemia","all-paediatric-high-risk","all-ph-like"],"sections":[],"technologies":[],"targets":[],"drugs":["clofarabine","cyclophosphamide","cytarabine","dasatinib","daunorubicin","dexamethasone","doxorubicin","etoposide","leucovorin","mercaptopurine","methotrexate","asparaginase","prednisone","thioguanine","vincristine"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02883049","phase":"3","setting":"A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations","sponsor":"National Cancer Institute (NCI)","started":"2012-02-29","startedType":"actual","yearReported":2024,"enrolled":5949,"enrolledBasis":"registry","outcomes":[{"endpoint":"DFS of Non-DS HR Post-induction Patients Receiving Intrathecal (IT) Methotrexate (MTX) Compared With Patients Receiving Intrathecal Triple Therapy (ITT) on a Modified Berlin-Frankfurt-Munster (MBFM) Interim Maintenance High-dose Methotrexate Backbone","primary":true,"unit":"%","arms":[{"name":"Non-DS HR B-ALL Arm A","n":868,"value":92.48,"note":"95% CI 90.7 to 94.3; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication"},{"name":"Non-DS HR B-ALL Arm B","n":866,"value":92.33,"note":"95% CI 90.5 to 94.2"}],"hr":1.022,"ci":[0.74,1.413],"p":"0.893","source":"https://clinicaltrials.gov/study/NCT02883049?tab=results"},{"endpoint":"DFS of Non-DS VHR Post-Induction Patients Who Receive a Modified MBFM-IMHDM Regimen That Contains a Second IM (Control Arm) Compared to Patients Receive the Cyclophosphamide + Etoposide Containing Regimen (Experimental Arm 1)","primary":true,"unit":"%","arms":[{"name":"Non-DS VHR B-ALL Control Arm","n":335,"value":77.11,"note":"95% CI 72.4 to 81.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-12), not from a publication"},{"name":"Non-DS VHR B-ALL Exp Arm1","n":488,"value":76.75,"note":"95% CI 72.8 to 80.7"}],"hr":1.019,"p":"0.556","source":"https://clinicaltrials.gov/study/NCT02883049?tab=results"}]},"route":"/trials/nct02883049/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-high-risk","kind":"cancer","name":"High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)","route":"/cancers/all-paediatric-high-risk/"},{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"},{"id":"all-ph-like","kind":"cancer","name":"Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL)","route":"/cancers/all-ph-like/"}],"drug":[{"id":"asparaginase","kind":"drug","name":"Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)","route":"/drugs/asparaginase/"},{"id":"clofarabine","kind":"drug","name":"Clofarabine","route":"/drugs/clofarabine/"},{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"dasatinib","kind":"drug","name":"Dasatinib","route":"/drugs/dasatinib/"},{"id":"daunorubicin","kind":"drug","name":"Daunorubicin","route":"/drugs/daunorubicin/"},{"id":"dexamethasone","kind":"drug","name":"Dexamethasone","route":"/drugs/dexamethasone/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"mercaptopurine","kind":"drug","name":"Mercaptopurine","route":"/drugs/mercaptopurine/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"},{"id":"thioguanine","kind":"drug","name":"Thioguanine","route":"/drugs/thioguanine/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}]}}