AMLM22/D1: This phase II trial is comparing the safety and effectiveness of a new, experimental treatment and standard of care in patients with acute myeloid leukaemia in complete first 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 patients with acute myeloid leukaemia in first complete remission

Exclusion

1. Chemotherapy or investigational agents within 28 days of planned study cycle 1 day
2. Impaired hematologic recovery 8 weeks after last chemotherapy
a. Grade 2 anemia (Hb <100g/L)
b. Grade 4 neutropenia (N <0.5 x 109/L)
c. Grade 3 thrombocyotopenia (Plt <50 x 109/L)
3. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of < 2 years
4. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
5. Prior bone marrow or stem cell transplantation

AMLM22/D1 specific exclusion criteria:
1. Presence of any general exclusion criteria outlined in in IAPC master protocol.
2. Prior solid organ transplant.
3. Cardiac abnormalities as evidenced by any of the following:
a. Clinically significant conduction abnormalities or uncontrolled arrhythmia.
b. Greater than or equal to New York Heart Association (NYHA) class II congestive cardiac failure and/or ejection fraction < 50% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
c. Unstable angina or myocardial infarction with coronary angioplasty/stenting within the last 3 months
d. ECG findings demonstrating baseline a QTcF interval greater than or equal to 480 ms
4. Increased bleeding risk as a result of:
a. Use of anticoagulants at therapeutic levels within 7 days prior to the first dose of Molibresib (GSK525762).
b. Evidence of active bleeding or major bleed within the last 3 months.
c. Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT]) greater than or equal to 1.2 x upper limit of normal (ULN)
5. Subject not able to comply with domain-specific contraception recommendations