{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"name":"MIRROS","nct_id":"NCT02545283","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=mirros-nct02545283. 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":"MIRROS","arms":[{"description":"Participants will receive induction therapy idasanutlin and cytarabine for 5 Days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or complete remission with incomplete blood count recovery (CRi), up to 28 additional days are allowed for blood count recovery, if needed.","label":"Idasanutlin plus Cytarabine","type":"EXPERIMENTAL"},{"description":"Participants will receive induction therapy idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in Cycle 1 (treatment cycle length=28 days). Responding participants may continue with consolidation therapy for a maximum of 2 additional cycles including idasanutlin matching placebo and cytarabine for 5 days followed by 23 days of rest in each cycle (treatment cycle length=28 days). After each cycle, for participants achieving CRp or CRi, up to 28 additional days are allowed for blood count recovery, if needed.","label":"Placebo plus Cytarabine","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2020-04-24","type":"ACTUAL"},"conditions":["Leukemia, Myeloid, Acute"],"enrollment":{"count":447,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cytarabine","otherNames":[],"type":"DRUG"},{"name":"Idasanutlin","otherNames":["RG7388"],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"OTHER"}],"last_update":"2022-01-11","lead_sponsor":"Hoffmann-La Roche","official_title":"A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-04-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival in TP53 WT Population","timeFrame":"From randomization to death from any cause (up to approximately 4.5 years)"}],"references":[{"citation":"Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Recher C, Rodriguez-Veiga R, Rollig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine +/- idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13.","pmid":"32167393","type":"DERIVED"}],"start_date":{"date":"2015-12-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)","url":"https://clinicaltrials.gov/study/NCT02545283"},"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/mirros-nct02545283"}