![free clinical trials for acute myeloid leukemia free clinical trials for acute myeloid leukemia](https://medicoapps.org/wp-content/uploads/2018/11/med_aml.jpg)
Based on the recommendation of the Independent Data Monitoring Committee, further enrollment into the study was prematurely discontinued due to evidence of benefit.Ĭonclusions: IVO+AZA significantly improved EFS, OS, and clinical response (CR, CR+CRh, ORR) compared with PBO+AZA in patients with IC-ineligible, newly diagnosed m IDH1 AML. Frequency of all-grade differentiation syndrome (DS) as assessed by investigators was 14.1% with IVO+AZA vs 8.2% with PBO+AZA, and that of grade ≥ 3 DS was 4.2% with IVO+AZA vs 4.1% with PBO+AZA. Common grade ≥ 3 AEs occurring in > 20% of patients receiving IVO+AZA vs PBO+AZA included febrile neutropenia (28.2% vs 34.2%), anemia (25.4% vs 26.0%), thrombocytopenia (23.9% vs 20.5%), and pneumonia (22.5% vs 28.8%). Sixty-six (93.0%) patients receiving IVO+AZA vs 69 (94.5%) patients receiving PBO+AZA experienced a grade ≥ 3 AE. Median OS with IVO+AZA was 24.0 months vs 7.9 months with PBO+AZA (HR = 0.44 P = 0.0005). EFS was statistically significant (HR = 0.33 P = 0.0011) in favor of the IVO+AZA arm. Thirty-nine (26.7%) patients remain on treatment (27/72 patients in the IVO+AZA arm vs 12/74 patients in the PBO+AZA arm). Sixteen (22.2%) patients receiving IVO+AZA had poor-risk genetics per ELN guidelines vs 20 (27.0%) patients receiving PBO+AZA. Fifty-four (75.0%) patients had de novo AML vs 18 (25.0%) with secondary AML in the IVO+AZA arm. Results: From 1 to 1, 146 patients were randomized: 72 to IVO+AZA (median age, 76.0 years) and 74 to PBO+AZA (median age, 75.5 years).
![free clinical trials for acute myeloid leukemia free clinical trials for acute myeloid leukemia](https://i.ytimg.com/vi/u-zoqCjo5QU/maxresdefault.jpg)
Key secondary endpoints: CR rate, overall survival (OS), CR + CR with partial hematologic recovery (CRh) rate, and objective response rate (ORR). failure to achieve complete remission by week 24, relapse from remission, or death from any cause). Primary endpoint: event-free survival (EFS time from randomization until treatment failure, i.e. Key eligibility: untreated AML (WHO criteria), centrally confirmed m IDH1 status, not eligible for IC, ECOG 0-2. Methods: In this global, double-blind, randomized, placebo-controlled, phase 3 study, patients were randomized 1:1 to IVO 500 mg once daily + AZA 75 mg/m 2 subcutaneously or intravenously for 7 days in 28-day cycles, or placebo + AZA (PBO+AZA), and stratified by region and de novo vs secondary AML. Data from a phase 1b study of 23 patients with newly diagnosed m IDH1 AML showed a favorable safety profile and encouraging clinical activity of ivosidenib + azacitidine (IVO+AZA NCT02677922). Ivosidenib – an oral, potent inhibitor of the mutant IDH1 (mIDH1) enzyme – is FDA-approved for adults with relapsed/refractory m IDH1 AML and adults with newly diagnosed m IDH1 AML who are ≥ 75 years or have comorbidities that preclude use of intensive induction chemotherapy (IC). Gianolio, PhD 11 *, Stephane de Botton, MD, PhD 12 * and Hartmut Döhner, MD 13ġHospital Universitari i Politècnic La Fe, Valencia, SpainĢInstitut Universitaire du Cancer de Toulouse Oncopole, CHU de Toulouse, Toulouse, FranceģHospital Universitario Germans Trias i Pujol-ICO Badalona, Josep Carreras Research Institute, Universitat Autònoma de Barcelona, Badalona, SpainĤDepartment of Hematology and Transplantology, Medical University of Gdansk, Gdansk, PolandĥInstitute of Hematology & Hospital of Blood Disease – Peking Union Medical College, Beijing, ChinaĦASST Grande Ospedale Metropolitano Niguarda, Milan, ItalyħHannover Medical School, Hannover, GermanyĨRibeirão Preto School of Medicine, University of São Paulo, São Paulo, BrazilĩPrincess Margaret Cancer Centre, Toronto, ON, Canadaġ0China Medical University, Taichung, Taiwanġ2Institut Gustave Roussy, Villejuif, Franceīackground: Somatic mutations in isocitrate dehydrogenase 1 ( IDH1) occur in 6–10% of patients with acute myeloid leukemia (AML). Daigle, MS 11 *, Jianan Hui, PhD 11 *, Vickie Zhang, PhD 11 *, Shuchi S. Schuh, MD 9, Su-Peng Yeh, MD 10 *, Scott R. Pau Montesinos, PhD, MD 1 *, Christian Recher, MD 2, Susana Vives, MD 3 *, Ewa Zarzycka, MD 4 *, Jianxiang Wang, MD 5, Giambattista Bertani, MD 6 *, Michael Heuser, MD 7, Rodrigo T.