AMLM22/D1: The 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.

Trial summary:

This study will evaluate the safety and efficacy of Molibresib for Acute Myeloid Leukemia

Receptor status / problem studied:

Acute myeloid leukaemia

Inclusion criteria

  • Provision of written informed consent
  • Provision of written informed consent to the ALLG NBCR
  • Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorizing HREC)
  • AML (excluding APL) in first complete remission with bone marrow blasts <5%
  • There is no AMLM22/D1 specific inclusion criteria. Inclusion to this domain is what is outlined above

Exclusion criteria

  • Chemotherapy or investigational agents within 28 days of planned study cycle 1 day
  • Impaired hematologic recovery 8 weeks after last chemotherap
    • 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)
  • History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of < 2 years
  • Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
  • Prior bone marrow or stem cell transplantation

AMLM22/D1 specific exclusion criteria:

  • Presence of any general exclusion criteria outlined in in IAPC master protocol.
  • Prior solid organ transplant.
  • 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
  • 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)
  • Subject not able to comply with domain-specific contraception recommendations

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