Trial purpose
Cancer treatment
Tumor type
Haematological
Age
16+
Clinical summary
Summary
Eligible participants will be randomised to receive Molibresib (investigational product) at recommended dose of 60mg daily, taken orally 28 days per (28 day) cycle; or standard of care, which is generally observation.
Conditions
This trial is treating people with Acute Myeloid Leukaemia
Eligibility
Inclusion
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%
1. Meets inclusion criteria outlined in IAPC master protocol. (the above)
2. Platelet count =100 x109/L and neutrophil count =0.5 x 109/L
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
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Australasian Leukaemia and Lymphoma Group (ALLG)
Scientific Title
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
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