{"preliminary_commentary":{"by_channel":{"bluesky_thread":15,"x_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02013648\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"NCT02013648","nct_id":"NCT02013648","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02013648. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients will receive induction therapy with daunorubicin 60 mg/m2/day administered on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 12mg²/day on days 1,3,5) and cytarabine 200 mg/m2/day administered by continuous IV infusion on days 1-7.\n\nPatients achieving PR only at the end of cycle 1 will receive a second induction cycle with daunorubicin 50 mg/m2/day (when daunorubicin is not available due to supply shortage: Idarubicin 10 mg²/day on days 1 and 3) administered on days 1-3 and cytarabine 200 mg/m2/day administered by cont. IV infusion daily on days 1-5.\n\nPatients will receive 4 cycles of consolidation therapy. Consolidation therapy consists of high-dose cytarabine 3 g/m2 (\\>60 years: 1 g/m2) q12h, days 1-3 administered intravenously over three hours.\n\nFollow-up period: There is no maintenance therapy in the standard arm. Patients will be closely followed, in particular for molecular disease persistence or molecular relapse.","label":"Standard arm","type":"ACTIVE_COMPARATOR"},{"description":"Patients will receive induction therapy with daunorubicin 60 mg/m2/day on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 12mg²/day on days 1,3,5) and cytarabine 200 mg/m2/day by cont. IV infusion on days 1-7. Patients will receive dasatinib 100 mg QD on days 8-21. Patients achieving PR only at the end of cycle 1 will receive a 2nd induction cycle with daunorubicin 50 mg/m2/day on days 1-3 (when daunorubicin is not available due to supply shortage: Idarubicin 10 mg²/day on days 1 and 3) and cytarabine 200 mg/m2/day by cont. IV infusion on days 1-5. Patients will receive dasatinib 100 mg QD on days 6-21.\n\nConsolidation therapy (4 cycles). Treatment consists of high-dose cytarabine 3 g/m2 (\\>60 years: 1 g/m2) q12h, days 1-3 iv over 3 hours. Patients will receive dasatinib 100 mg QD on days 4-21. Maintenance therapy: Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse).","label":"Investigational arm","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-02","type":"ACTUAL"},"conditions":["Acute Myeloid Leukemia (AML)"],"enrollment":{"count":204,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Dasatinib","otherNames":["Sprycel"],"type":"DRUG"},{"name":"Cytarabine","otherNames":["ARA-cell"],"type":"DRUG"},{"name":"Daunorubicin","otherNames":["Daunoblastin"],"type":"DRUG"},{"name":"Idarubicin","otherNames":[],"type":"DRUG"}],"last_update":"2024-02-23","lead_sponsor":"University of Ulm","official_title":"Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2024-02","type":"ACTUAL"},"primary_outcomes":[{"measure":"Event-free Survival","timeFrame":"4 years"}],"references":[{"citation":"Dohner H, Spath D, Saadati M, Fiedler W, Gotze K, Koller E, Westermann J, Vogel W, Heuser M, Lubbert M, Tischler HJ, Germing U, Teichmann LL, Fransecky L, Wolfler A, Nachbaur D, Hertenstein B, Schroers R, Martens U, von Harsdorf S, Radsak M, Aschauer G, Weisshaar S, Corbacioglu A, Schrade A, Gaidzik VI, Thol F, Paschka P, Bullinger L, Benner A, Dohner K, Ganser A. A phase 3 study of intensive chemotherapy with or without dasatinib in core-binding factor acute myeloid leukemia. Blood. 2026 Apr 9;147(15):1735-1748. doi: 10.1182/blood.2025030722.","pmid":"41490515","type":"DERIVED"},{"citation":"Paschka P, Schlenk RF, Weber D, Benner A, Bullinger L, Heuser M, Gaidzik VI, Thol F, Agrawal M, Teleanu V, Lubbert M, Fiedler W, Radsak M, Krauter J, Horst HA, Greil R, Mayer K, Kundgen A, Martens U, Heil G, Salih HR, Hertenstein B, Schwanen C, Wulf G, Lange E, Pfreundschuh M, Ringhoffer M, Girschikofsky M, Heinicke T, Kraemer D, Gohring G, Ganser A, Dohner K, Dohner H. Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. Leukemia. 2018 Jul;32(7):1621-1630. doi: 10.1038/s41375-018-0129-6. Epub 2018 Apr 17.","pmid":"29720733","type":"DERIVED"}],"start_date":{"date":"2014-07"},"study_type":"INTERVENTIONAL","title":"Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)","url":"https://clinicaltrials.gov/study/NCT02013648"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02013648"}