Oral Azacitidine+Best Support Care in Myelodysplastic Syndrome

AZA-MDS-003 - A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Placebo Plus Best Supportive Care in Subjects with Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Walton, Sherri

    Trial Phone: 321.841.1907

  • IRB No: 14.054.04

    Protocol Abbrev: AZA-MDS-003

    Principal Investigator: Daniel Ari Landau, MD

    Sub Investigators: Baidas, Said MD; Hajdenberg, Julio MD; Sarriera, Jose MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: AZA-MDS-003

    Treatment: Medication

    Applicable Disease Sites: Hematology

    Therapies Involved: Drug: Oral Azacitidine

    ClinicalTrials.gov ID: NCT01566695

  • Objective

    Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

  • Key Eligibility

    •  Have a documented diagnosis of MDS
    •  Anemia that requires red blood cell transfusions
    •  Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization