A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in AML patients =65 years of age not eligible for intensive chemotherapy - DELTA

Technische Universität Dresden0 个研究点目标入组 238 人开始时间: 2015年1月29日最近更新: 2021年4月5日

试验速览

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•Newly diagnosed AML (including therapy-related or after antecedent MDS) other than APL according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In AML defined by cytogenetic aberrations according to WHO the proportion of blasts may be <20%
•Age = 65 years
•ECOG performance status 0-3
•Patients not eligible for intensive induction therapy
•Planned therapy with DAC
•Platelet count <75 Gpt/L taken within 4 weeks prior to randomization
•Signed Informed Consent
•Adequate liver function as assessed by the following laboratory requirements:
•o Total bilirubin = 3 times the upper limit of normal (except for Gilbert’s Syndrome)
•o ALT and AST = 3 times upper limit of normal
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 238

•Acute promyelocytic leukemia (APL)
•History of MDS or AML treatment with TPO-R agonists (Revolade, NPlate or other TPO-R agonists), hypomethylating agents or intensive chemotherapy
•NYHA stage = 2 due to heart insufficiency
•Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
•Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication
•Active and uncontrolled infections
•positive Human Immunodeficiency Virus (HIV) or positive Hepatitis B or C serology
•Patients unable to swallow medication
•Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to eltrombopag or DAC or excipients that contraindicate their participation.

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