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A Study of the Pharmacokinetics, Safety, and Efficacy of ASTX727
||ASTX727-07 - A Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination with Venetoclax in Adult Patients with Acute Myeloid Leukemia
Acute Myeloid Leukemia
||Zheng (Frank) Zhou, MD
This study aims to learn more about the investigational drug, ASTX727, and another drug, venetoclax, when given in combination. It also aims to evaluate potential pharmocokinetics (PK) interactions for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy.
- Histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2016 criteria.
- Projected life expectancy of at least 3 months.
- Participants must be considered ineligible for intensive induction chemotherapy defined by the following:
- Age 75 years or older, or
- Age 18 to 74 years with at least one of the following comorbidities:
- Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina),
- Severe pulmonary disorder (eg, diffusing lung capacity for carbon monoxide DLCO ≤65% or forced expiratory volume in 1 second [FEV1] ≤65%),
- Creatinine clearance ≥30 mL/min to <45 mL/min, iv) Moderate hepatic impairment with total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN)
- History of myeloproliferative neoplasm including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Known active central nervous system involvement from AML.
- Known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax). Human immunodeficiency virus testing will be performed at Screening, only if indicated per local guidelines or institutional standards.
- Screening: If you agree to volunteer for this study, we will collect information about you, and you will have tests to make sure that you can take part. This includes collecting your medical history, any relevant anticancer therapies and current medicines, having a physical exam, completing an Electrocardiogram (ECG), blood draw, and a urine sample
- Treatment: you will be asked to come to the study center for a total of 10 visits in Cycle 1, 8 visits in Cycle 2, and 4 visits from Cycle 3 onwards. Your study doctor may ask you to come in for additional visits depending on your transfusion needs or supportive care. You will be asked to take the study drug, complete study diaries, and give additional blood samples and urine samples.
- Follow-ups: You will be asked to return to the clinic about 30 days after your last dose of study drug or within 3 days of starting a new treatment and the study doctor will continue to evaluate the long-term effects of the study drug by contacting you or your preferred family contact every 3 months.