AMLM22/D2-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 subjects with acute myeloid leukaemia in first complete remission. Domain 2 is investigating the safety and efficacy of Venetoclax as a maintenance therapy alone or in combination with low dose cytarabine (LDAC).
- Conditions
- Acute Myeloid Leukaemia (AML)Cancer - Leukaemia - Acute leukaemia
- Registration Number
- ACTRN12619000280101
- Lead Sponsor
- Australian Leukaemia and Lymphoma Group (ALLG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
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. Subject has achieved remission after intensive chemotherapy (e.g. 7+3 or equivalent +/- subsequent consolidation therapy)
6. ECOG 0-2
7. Subject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection
8. Subject must have adequate liver function as demonstrated by:
a.aspartate aminotransferase (AST) greater than or equal to 3.0 × ULN
b.alanine aminotransferase (ALT) greater than or equal to 3.0 × ULN
c.bilirubin greater than or equal to 1.5 × ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
9. Agrees to follow the recommended contraception procedures for this treatment domain
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
6. There is an intent to undertake a stem cell transplant procedure within the next 3 months
7. Subject is HIV positive
8. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
a.Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
b.Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
9. Treatment with any of the following within 7 days prior to the first dose of study drug:
a.Steroid therapy for anti-neoplastic intent
b.Moderate or strong CYP3A inducers
c.Moderate or strong cytochrome CYP3A inhibitors may be used with caution with appropriate dose modifications for venetoclax
10. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
a.Grapefruit or grapefruit products
b.Seville oranges (including marmalade containing Seville oranges)
c.Star fruit
11. Subject not able to comply with domain-specific contraception recommendations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure-free survival - this is the time from randomisation until the time of the earliest leukaemia event (relapse). Data to monitor failure-free survival (disease monitoring and minimal residual disease (MRD) testing) will be collected from patient's at various protocol specified times points throughout the study.[ Time from randomisation until the time of the earliest leukaemia event- either MRD progression, MRD relapse, clinical relapse or death. <br>Patients will be followed for survival, by telephone, every month for the first year and then every 3 months until death, withdrawal of consent for further follow-up, study end, or until a subject is lost to follow-up.<br>Treatment is expected to be for up to 24months<br>Follow up will continue until death, withdrawal of consent from study or until a patient is lost to follow up]
- Secondary Outcome Measures
Name Time Method