None listed
Conditions
Brief summary
This study will evaluate the safety and efficacy of Molibresib for Acute Myeloid Leukemia Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard care which generally observation. Participants in the other group will receive the drug Molibresib daily for a total of 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) as well as an ECG to monitor heart function. Molibresib is known to have adverse effects on the heart therefore, participants will also have a MUGA (MUltiple Gated Acquisition scan) or ECHO (echocardiogram) at screening, cycle 2 and then every 12 weeks thereafter. We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available ,become accessible to the general population at faster than the normal process.
Interventions
Domain 1 is AMLM22/D1, it has 2 treatment arms:
Arm 1: Molibresib (investigational product). Recommended dose of Molibresib is 40mg daily, taken orally on days 1-14 of each 28 day cycle. Total treatment duration is expected to be 24 months.
Arm 2: standard of care (generally observation)
Patients will be asked to return any unused molibresib tablets at each visit, for drug accountability
Sponsors
Australian Leukaemia and Lymphoma Group (ALLG)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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% 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 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
Outcome results
None listed