{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":1},"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":[["venetoclax","CLIA"],["CLIA"]],"indication":"acute myeloid leukemia or high-risk myelodysplastic syndrome","name":"NCT02115295","nct_id":"NCT02115295","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02115295. 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":"INDUCTION: Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-5 and idarubicin IV over 30-60 minutes on days 1-3. Patients with untreated AML and MDS also receive venetoclax PO on days 2-8. AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD on days 1-14. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nCONSOLIDATION: Patients receive cladribine IV and cytarabine IV over 1-2 hours on days 1-3 and idarubicin IV over 30-60 minutes on days 1-2. Patients with untreated AML and MDS also receive venetoclax PO on days 2-8. AML patients with known FLT3-ITD or FLT3 kinase domain mutations may receive midostaurin PO BID on days 6-19 or gilteritinib PO QD. Treatment repeats every 28 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity.","label":"Treatment (cladribine, cytarabine, idarubicin)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2030-05-31","type":"ESTIMATED"},"conditions":["Acute Biphenotypic Leukemia","Acute Myeloid Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Blasts 10 Percent or More of Peripheral Blood White Cells","de Novo Myelodysplastic Syndrome","Myelodysplastic Syndrome","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Acute Myeloid Leukemia","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Secondary Acute Myeloid Leukemia","Untreated Adult Acute Myeloid Leukemia"],"enrollment":{"count":508,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Cladribine","otherNames":["2-CdA","2CDA","CdA","Cladribina","Leustat","Leustatin","Leustatine","RWJ-26251"],"type":"DRUG"},{"name":"Cytarabine","otherNames":[".beta.-Cytosine arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453"],"type":"DRUG"},{"name":"Gilteritinib","otherNames":["ASP-2215","ASP2215","Xospata"],"type":"DRUG"},{"name":"Idarubicin","otherNames":["4-Demethoxydaunomycin","4-demethoxydaunorubicin","4-DMDR"],"type":"DRUG"},{"name":"Laboratory Biomarker Analysis","otherNames":[],"type":"OTHER"},{"name":"Midostaurin","otherNames":["CGP 41251","CGP41251","N-Benzoyl-Staurosporine","N-Benzoylstaurosporine","PKC-412","PKC412","Rydapt"],"type":"DRUG"},{"name":"Venetoclax","otherNames":["ABT-0199","ABT-199","ABT199","GDC-0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"}],"last_update":"2026-05-20","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML","overall_status":"RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2030-05-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Complete response (CR) rate","timeFrame":"Up to 12 months"}],"references":[{"citation":"Goulart H, Jabbour E, Short NJ, Kadia TM, Pemmaraju N, Takahashi K, Ravandi F, Konopleva M, Jain N. A Phase I/II Trial of Ruxolitinib with Chemotherapy for Patients with Relapsed and/or Refractory Philadelphia-like Acute Lymphoblastic Leukemia. Clin Lymphoma Myeloma Leuk. 2025 Nov;25(11):800-807. doi: 10.1016/j.clml.2025.05.013. Epub 2025 May 20.","pmid":"40500616","type":"DERIVED"},{"citation":"Goulart H, Kantarjian H, Borthakur G, Daver N, DiNardo CD, Jabbour E, Pemmaraju N, Alvarado Y, Atluri H, Yilmaz M, Haddad FG, Marx KR, Rausch C, Loghavi S, Jain N, Garcia-Manero G, Ravandi-Kashani F, Kadia TM. Cladribine, idarubicin, and cytarabine (CLIA) for patients with relapsed and/or refractory acute myeloid leukemia: A single-center, single-arm, phase 2 trial. Cancer. 2025 Apr 15;131(8):e35840. doi: 10.1002/cncr.35840.","pmid":"40193193","type":"DERIVED"},{"citation":"Kadia TM, Reville PK, Borthakur G, Yilmaz M, Kornblau S, Alvarado Y, Dinardo CD, Daver N, Jain N, Pemmaraju N, Short N, Wang SA, Tidwell RSS, Islam R, Konopleva M, Garcia-Manero G, Ravandi F, Kantarjian HM. Venetoclax plus intensive chemotherapy with cladribine, idarubicin, and cytarabine in patients with newly diagnosed acute myeloid leukaemia or high-risk myelodysplastic syndrome: a cohort from a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2021 Aug;8(8):e552-e561. doi: 10.1016/S2352-3026(21)00192-7.","pmid":"34329576","type":"DERIVED"},{"citation":"Morita K, Kantarjian HM, Wang F, Yan Y, Bueso-Ramos C, Sasaki K, Issa GC, Wang S, Jorgensen J, Song X, Zhang J, Tippen S, Thornton R, Coyle M, Little L, Gumbs C, Pemmaraju N, Daver N, DiNardo CD, Konopleva M, Andreeff M, Ravandi F, Cortes JE, Kadia T, Jabbour E, Garcia-Manero G, Patel KP, Futreal PA, Takahashi K. Clearance of Somatic Mutations at Remission and the Risk of Relapse in Acute Myeloid Leukemia. J Clin Oncol. 2018 Jun 20;36(18):1788-1797. doi: 10.1200/JCO.2017.77.6757. Epub 2018 Apr 27.","pmid":"29702001","type":"DERIVED"}],"start_date":{"date":"2014-05-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","url":"https://clinicaltrials.gov/study/NCT02115295"},"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/nct02115295"}