{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":2},"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":[["CPX-351"],["TBF"],["Mini-TBF"]],"indication":"AML or high-risk MDS undergoing allogeneic SCT","name":"COSI","nct_id":"NCT04217278","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=cosi-nct04217278. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"COSI","arms":[{"description":"First Randomisation (closed to recruitment) - control arm: Intermediate dose Cytarabine (1g/m\\^2 administered by intravenous infusion over 2 hours on days 1-5 inclusive)","label":"R1: Intermediate dose Cytarabine","type":"ACTIVE_COMPARATOR"},{"description":"First Randomisation (closed to recruitment) - experimental arm: Vyxeos (29mg/65mg/m\\^2 administered by intravenous infusion over 90 minutes on days 1 and 3)","label":"R1: Vyxeos","type":"EXPERIMENTAL"},{"description":"Second Randomisation - under 55 years - control arm: Fludarabine (40mg/m\\^2 days -7, -6, -5, and -4), Busulphan (3.2mg/kg days -7, -6, -5 and -4)","label":"R2: FB4","type":"ACTIVE_COMPARATOR"},{"description":"Second Randomisation - under 55 years - experimental arm: Thiotepa (5mg/kg day -7 and -6), Busulphan (3.2mg/kg days -5, -4 and -3), Fludarabine (50mg/m\\^2 days -5, -4 and -3)","label":"R2: TBF","type":"EXPERIMENTAL"},{"description":"Third Randomisation - 55 years and over (or under 55 with comorbidities) - control arm: Fludarabine (30mg/m\\^2 days -6, -5, -4, -3 and -2), Busulphan (3.2mg/kg days -6 and -5)","label":"R3: FB2","type":"ACTIVE_COMPARATOR"},{"description":"Third Randomisation - 55 years and over (or under 55 with comorbidities) - experimental arm: Thiotepa (5mg/kg day -6), Busulphan (3.2mg/kg days -5 and -4), Fludarabine (50mg/m\\^2 days -5, -4, and -3)","label":"Mini-TBF","type":"EXPERIMENTAL"}],"collaborators":["Jazz Pharmaceuticals","Adienne SA"],"completion_date":{"date":"2026-05","type":"ESTIMATED"},"conditions":["Acute Myeloid Leukaemia","High-risk Myelodysplastic Syndrome"],"enrollment":{"count":333,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Vyxeos","otherNames":["CPX-351"],"type":"DRUG"},{"name":"Fludarabine","otherNames":["Fludara"],"type":"DRUG"},{"name":"Busulphan","otherNames":["Busulfan","Bulsivex"],"type":"DRUG"},{"name":"Thiotepa","otherNames":["Tepadina"],"type":"DRUG"},{"name":"Cytarabine","otherNames":["Ara-C","Cytosine arabinoside"],"type":"DRUG"}],"last_update":"2026-05-05","lead_sponsor":"University of Birmingham","official_title":"An International Randomised Clinical Trial of Therapeutic Interventions to Assess the Effects on Outcome in Adults With Acute Myeloid Leukaemia and High Risk Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation.","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2026-05","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall survival (all randomisations)","timeFrame":"12 and 24 months"}],"references":[],"start_date":{"date":"2020-01-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT","url":"https://clinicaltrials.gov/study/NCT04217278"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/cosi-nct04217278"}