AMLM22/D1
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:
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.
Receptor status / problem studied:
Inclusion criteria
1) Provision of written informed consent.
2) Provision of written informed consent to the ALLG NBCR.
3) Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorizing HREC).
4) AML (excluding APL) in first complete remission with bone marrow blasts <5%.
5) Meets inclusion criteria outlined in IAPC master protocol. (the above).
6) Platelet count =100 x109/L and neutrophil count =0.5 x 109/L.
Exclusion criteria
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.
Trial Title
AMLM22/D1
Diagnosis
Leukaemia
Type of trial
Collaborative
Type of treatement
Haematology
Phase
II