{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"Total XVII","nct_id":"NCT03117751","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=total-xvii-nct03117751. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients with low-risk B ALL and LLy will have Induction (6 weeks), Consolidation (8 weeks), and Continuation (120 weeks). During Remission Induction therapy, prednisone dose is 40mg/m\\^2 and 1-2 doses of daunorubicin (based on day 8 peripheral blood MRD in patients with ETV6-RUNX1 or hyperdiploid) are given. Dasatinib is given for patients with ABL-class fusion. Blinatumomab will be given to patients with certain genetic subtypes and those with Down syndrome.\n\nInterventions: Prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, thioguanine, methotrexate, dexamethasone, blinatumomab.","label":"B-ALL and B-LLy, Low-risk","type":"EXPERIMENTAL"},{"description":"Induction (6wks), Early Intensification (4wks), Consolidation (8wks) and Continuation (120 wks). Remission Induction: Prednisone dose is 40mg/m\\^2 and 2 doses daunorubicin are given. Dasatinib: given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib: given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5%, LLy patients who don't qualify for complete response at end of Remission Induction and all patients with ETP and T/M MPAL. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD \\>5%. Blinatumomab will be given to patients with residual disease at the end of induction (≥0.01% and \\<1%), certain genetic subtypes and Down syndrome.\n\nInterventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, thioguanine, methotrexate, dexamethasone, doxorubicin","label":"B-ALL and B-LLy, Standard-risk","type":"EXPERIMENTAL"},{"description":"Induction (6 weeks), Early Intensification (4 weeks), Consolidation (8 weeks), and Immunotherapy (chimeric antigen receptor \\[CAR\\] T cells). Patients who do not respond to Immunotherapy will receive Reintensification therapy. During Remission Induction therapy, prednisone dose is 40mg/m\\^2 and 2 doses of daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib are given as done for patients with standard-risk B-ALL but are discontinued in Immunotherapy and Reintensification therapy. Blinatumomab will be given to patients who are not able to receive CAR T cell therapy and patients with certain genetic subtypes and those with Down syndrome.\n\nInterventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, etoposide, dexamethasone, clofarabine, thioguanine, methotrexate.","label":"B-ALL and B-LLy, High-risk","type":"EXPERIMENTAL"},{"description":"Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Continuation (120 wks). During Remission Induction therapy, prednisone dose is 60mg/m\\^2 and 3 doses daunorubicin are given. Dasatinib is given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib is given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5% and all patients with ETP and T/M MPAL and LLy patients who don't qualify for complete response at end of Remission Induction. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD ≥ 5%.\n\nInterventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, dexamethasone, doxorubicin, nelarabine, thioguanine.","label":"T-ALL and T-LLy, Standard-risk","type":"EXPERIMENTAL"},{"description":"Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Reintensification. During Remission Induction therapy, prednisone dose is 60mg/m\\^2 and 3 doses daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib given as done for patients with standard-risk T-ALL but are discontinued in Reintensification therapy.\n\nInterventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, etoposide, dexamethasone, clofarabine, vorinostat, idarubicin, nelarabine, thioguanine..","label":"T-ALL and T-LLy, High-risk","type":"EXPERIMENTAL"},{"description":"Patients with the CEP72 rs904627T/T genotype (\\~16% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive either 1.5 mg/m\\^2 or 1 mg/m\\^2 of vincristine after Continuation Week 1. Patients in low- risk will complete vincristine in Week 49 and those in standard/high-risk will complete in Week 101.\n\nIntervention: vincristine.","label":"ALL, CEP72 T/T, Vincristine","type":"EXPERIMENTAL"},{"description":"Patients with either a CEP72 rs904627 C/T or C/C genotype (\\~84% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive vincristine (2 mg/m\\^2 per dose except during Reinduction I and Reinduction II when 3 weekly doses of 1.5 mg/m\\^2 will be given) and dexamethasone pulses through Week 49 of Continuation Treatment or through Week 101 of Continuation Treatment. Patients at low-risk will complete vincristine in Week 49.\n\nInterventions: vincristine, dexamethasone, methotrexate, mercaptopurine.","label":"ALL, CEP72 C/T or C/C, Vincristine","type":"EXPERIMENTAL"}],"collaborators":["Incyte Corporation","Amgen","Servier"],"completion_date":{"date":"2028-09-30","type":"ESTIMATED"},"conditions":["Acute Lymphoblastic Leukemia","Acute Lymphoblastic Lymphoma"],"enrollment":{"count":790,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Prednisone","otherNames":["Prednisolone","Deltasone","Meticorten","Orasone®","Liquid Pred","Pediapred®","Sterapred®"],"type":"DRUG"},{"name":"Vincristine","otherNames":["Vincristine sulfate","Oncovin®","VCR","LCR"],"type":"DRUG"},{"name":"Daunorubicin","otherNames":["Daunomycin","rubidomycin","Cerubidine®"],"type":"DRUG"},{"name":"Pegaspargase","otherNames":["PEG-asparaginase","PEGLA","PEG-L-asparaginase","polyethylene glycol-L-asparaginase","Oncaspar®"],"type":"DRUG"},{"name":"Erwinase®","otherNames":["Erwinia chrysanthemi","Asparaginase Erwinia chrysanthemi","Erwinaze^TM","Crisantaspase"],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":["Cytoxan®"],"type":"DRUG"},{"name":"Cytarabine","otherNames":["Cytosine arabinoside","Ara-C","Cytosar®"],"type":"DRUG"},{"name":"Mercaptopurine","otherNames":["6-MP","Purinethol®","Purixan^TM","6-mercaptopurine"],"type":"DRUG"},{"name":"Dasatinib","otherNames":["Sprycel®"],"type":"DRUG"},{"name":"Methotrexate","otherNames":["MTX","amethopterin","Trexall®"],"type":"DRUG"},{"name":"Blinatumomab","otherNames":["Blincyto®"],"type":"DRUG"},{"name":"Ruxolitinib","otherNames":["Jakafi®"],"type":"DRUG"},{"name":"Bortezomib","otherNames":["Velcade®"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":["Decadron®","Hexadrol®","Dexone®","Dexameth®"],"type":"DRUG"},{"name":"Doxorubicin","otherNames":["Adriamycin®"],"type":"DRUG"},{"name":"Etoposide","otherNames":["Etoposide Phosphate","VePesid®","Etopophos®","VP-16"],"type":"DRUG"},{"name":"Clofarabine","otherNames":["Clolar®"],"type":"DRUG"},{"name":"Vorinostat","otherNames":["Zolinza®","Suberoylanilide Hydroxamic Acid","SAHA"],"type":"DRUG"},{"name":"Idarubicin","otherNames":["Idarubicin HCl","4-Demethoxydaunorubicin","4-DMD","DMDR","Idamycin PFS®"],"type":"DRUG"},{"name":"Nelarabine","otherNames":["Arranon®","Atriance®","Compound 506U78"],"type":"DRUG"},{"name":"Thioguanine","otherNames":["6-thioguanine","Tioguanine","2-amino-1,7-dihydro-6H-purine-6-thione","WR-1141","Tabloid®","Lanvis®"],"type":"DRUG"},{"name":"Asparaginase Erwinia chrysanthemi (recombinant)-rywn","otherNames":["Rylaze™","Recombinant Erwinia"],"type":"DRUG"},{"name":"Calaspargase Pegol","otherNames":["ASPARLAS"],"type":"DRUG"}],"last_update":"2026-06-17","lead_sponsor":"St. Jude Children's Research Hospital","official_title":"Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2026-09-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Event-free survival of ALL patients (EFS)","timeFrame":"At 3.5 years after enrollment of the last participant"},{"measure":"Proportion of patients with CEP72TT genotype who develop two or more episodes of Grade 2 or higher neuropathy during Continuation","timeFrame":"At 6 months after the last randomized patient completes Continuation Treatment (Week 120)."},{"measure":"Cumulative incidence of Grade 2 or higher neuropathy in patients with CEP72 CC or CT genotype","timeFrame":"After the last randomized patient is followed for 1 year after Week 101 of Continuation therapy"}],"references":[{"citation":"Montanaro A, Monica G, Zamponi R, D'Antuono A, Andreani A, Andrei P, Su AH, Ciringione A, Sammarelli G, Todaro G, Rosati R, La Starza R, Mecucci C, Elia L, Gherli A, Vento F, Simoncini E, Lorusso B, Lagrasta CAM, Giaimo M, Pagliaro L, Marchesini M, Jimenez CR, Quaini F, Stegmaier K, Roti G. Inhibition of the atypical kinase WNK1 as a therapeutic strategy in TAL-related T-cell acute lymphoblastic leukemia. Blood. 2026 Sep 10;148(11):1423-1439. doi: 10.1182/blood.2025029901.","pmid":"42154791","type":"DERIVED"}],"start_date":{"date":"2017-03-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma","url":"https://clinicaltrials.gov/study/NCT03117751"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/total-xvii-nct03117751"}