AMLM22/D3: Testing whether a new drug (called AZD5153) is safe and effective as maintenance therapy for people with acute myeloid leukaemia in first complete remissionThe International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukaemia in first complete remission. Domain 3 is investigating the safety and efficacy of an Astrazeneca drug labelled AZD5153 as a maintenance therapy option.

Exclusion

1. Chemotherapy or investigational agents within 28 days of planned study cycle 1 day 1
2. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of less than 2 years
3. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
4. Prior bone marrow or stem cell transplantation

AMLM22/D3 specific exclusion criteria:
1. Presence of any general exclusion criteria outlined in in IAPC master protocol.
2. Platelet count greater than or equal to 100 x 10^9 /L
3. Increased bleeding risk as a result of:
a. Use of parenteral anticoagulants at therapeutic levels, warfarin or direct oral anticoagulants within 14 days prior to the first dose of AZD5153.
b. Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT]) less than or equal to 1.5 x upper limit of normal (ULN)
4. Cardiac abnormalities as evidenced by any of the following:
a. Clinically significant conduction abnormalities or uncontrolled arrhythmia.
b. Uncontrolled hypertension
c. Greater than or equal to New York Heart Association (NYHA) class II congestive cardiac failure and/or left ventricular ejection fraction < 50% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
d. ECG findings demonstrating baseline a QTcF interval greater than or equal to 450 ms
5. Subject not able to comply with domain-specific contraception recommendations below:
a. Female patients must use two highly effective contraceptive measures. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse.
b. Female patients must not be breast-feeding and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
i. Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment.
ii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation.