{"commentary":{"count":11,"free_build_floor":8,"listing_floor":3,"by_channel":{"podcast":6,"x_thread":3,"youtube":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03914625\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT03914625","nct_id":"NCT03914625","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03914625. The price is fixed at order. We build the report after 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: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Arm A: See detailed description.","label":"Arm A (SR-Avg control)","type":"ACTIVE_COMPARATOR"},{"description":"Arm B: See detailed description.","label":"Arm B (SR-Avg experimental)","type":"EXPERIMENTAL"},{"description":"Arm C: See detailed description.","label":"Arm C (SR-High Control)","type":"ACTIVE_COMPARATOR"},{"description":"Arm D See detailed description.","label":"Arm D (SR-High experimental)","type":"EXPERIMENTAL"},{"description":"See detailed description.","label":"B-LLy","type":"EXPERIMENTAL"},{"description":"See detailed description.","label":"DS B-ALL","type":"EXPERIMENTAL"},{"description":"See detailed description.","label":"NCI SR or HR DS B-ALL","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Down Syndrome"],"enrollment":{"count":6720,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Asparaginase Erwinia chrysanthemi","type":"DRUG"},{"name":"Blinatumomab","type":"BIOLOGICAL"},{"name":"Cyclophosphamide","type":"DRUG"},{"name":"Cytarabine","type":"DRUG"},{"name":"Dexamethasone","type":"DRUG"},{"name":"Doxorubicin Hydrochloride","type":"DRUG"},{"name":"Leucovorin Calcium","type":"DRUG"},{"name":"Mercaptopurine","type":"DRUG"},{"name":"Mercaptopurine Oral Suspension","type":"DRUG"},{"name":"Methotrexate","type":"DRUG"},{"name":"Pegaspargase","type":"DRUG"},{"name":"Prednisolone","type":"DRUG"},{"name":"Prednisone","type":"DRUG"},{"name":"Radiation Therapy","type":"RADIATION"},{"name":"Radiation Therapy","type":"RADIATION"},{"name":"Thioguanine","type":"DRUG"},{"name":"Vincristine Sulfate","type":"DRUG"}],"last_update":"2026-10-01","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-09-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Disease free survival (DFS) in randomization eligible patients with higher risk features (SR-High) or standard risk average (SR-Avg) B-ALL patients based on randomization with addition of blinatumomab","timeFrame":"5.3 years"},{"measure":"DFS in boys in the SR-favorable subset of SR B-ALL with or without Down syndrome (DS)","timeFrame":"5.1 years"}],"references":[{"citation":"Gupta S, Rau RE, Kairalla JA, Rabin KR, Wang C, Angiolillo AL, Alexander S, Carroll AJ, Conway S, Gore L, Kirsch I, Kubaney HR, Li AM, McNeer JL, Militano O, Miller TP, Moyer Y, O'Brien MM, Okada M, Reshmi SC, Shago M, Wagner E, Winick N, Wood BL, Haworth-Wright T, Zaman F, Zugmaier G, Zupanec S, Devidas M, Hunger SP, Teachey DT, Raetz EA, Loh ML. Blinatumomab in Standard-Risk B-Cell Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2025 Feb 27;392(9):875-891. doi: 10.1056/NEJMoa2411680. Epub 2024 Dec 7.","pmid":"39651791","type":"DERIVED"},{"citation":"Sora F, Annunziata M, Laurenti L, Giammarco S, Chiusolo P, Innocenti I, Autore F, Metafuni E, Galli E, Bacigalupo A, Ferrara F, Sica S. Blinatumomab as a successful and safe therapy in Down syndrome patients with relapsed/refractory b-precursor acute lymphoblastic leukaemia: Case reports and literature review. Pediatr Blood Cancer. 2021 Jul;68(7):e29044. doi: 10.1002/pbc.29044. Epub 2021 Apr 12. No abstract available.","pmid":"33844429","type":"DERIVED"}],"start_date":{"date":"2019-07-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia","url":"https://clinicaltrials.gov/study/NCT03914625"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03914625"}