Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02287233) looked at a combination of two medicines — venetoclax and low-dose cytarabine (LDAC) — in people with a type of blood cancer called acute myeloid leukaemia (AML). The trial had two stages: a smaller Phase 1 stage to check dosing, involving 8 people receiving a 600 mg dose of venetoclax and 10 people receiving an 800 mg dose; and a larger Phase 2 stage involving 76 people all receiving the 600 mg dose. Notably, zero participants were recorded as having "completed" the study across all three groups, meaning all participants left the study before its formal end — the reasons for this are not broken down further in the reported data. The reported data shows that in Phase 1, the trial measured whether participants experienced what are called "dose-limiting toxicities" (DLTs) — meaning serious or life-threatening side effects during the first treatment cycle that would indicate a dose was too high. In the 600 mg group, zero out of 8 participants had a DLT recorded. In the 800 mg group, 1 out of 10 participants had a DLT recorded. The trial also tracked how the medicines moved through the bloodstream. For venetoclax, the reported peak blood concentration reached roughly 2.04–2.92 µg/mL in the 600 mg group and 2.26–2.36 µg/mL in the 800 mg group, with peak levels occurring somewhere between 4 and 8 hours after dosing. For cytarabine, peak blood concentrations were similar across both groups (around 166–175 ng/mL) and were reached very quickly, at approximately 0.3 hours after dosing. The reported data covers only these Phase 1 measurements; detailed outcome numbers for the larger Phase 2 group were not reported in the structured results data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Leukaemia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You must be 65 years of age or older for most parts of the trial; however, for one specific group (Cohort C), you must be either 75 or older, OR between 60 and 74 with at least one health condition that makes you unable to tolerate intensive chemotherapy (confirm with trial site)
- If you are aged 60–74 and in Cohort C, qualifying health conditions may include: a limited ability to carry out daily activities (ECOG score of 2–3); a heart condition such as heart failure, low heart pumping function, or stable angina; reduced lung function based on breathing tests; reduced kidney function within a specific range; moderate liver problems; or another condition your doctor judges to make intensive chemotherapy unsuitable (confirm with trial site)
- You must be expected to live for at least 12 weeks
- You must have been diagnosed with a type of blood cancer called AML (confirmed by laboratory testing) and be considered unsuitable for standard intensive chemotherapy due to health conditions or other factors
- You must not have had any previous treatment for AML, except for a medication called hydroxyurea, which may be used during the first cycle of the trial
- You may have previously been treated for a related blood condition called Myelodysplastic Syndrome (MDS)
- Your kidneys must be working well enough, with a kidney function score of at least 30 mL/min (measured by a urine test or a calculation formula)
- Your liver must be functioning at an acceptable level based on specific blood test results (confirm exact values with trial site)
- If you are male, you must agree to use protected sex and avoid sperm donation from the start of treatment until 180 days after your last dose
- If you are female, you must either have gone through menopause (no periods for 12 or more months without another medical explanation) or have had a surgical procedure that means you cannot become pregnant (such as removal of both ovaries, both fallopian tubes, or the womb)
- You must be willing and able to sign a consent form before any trial procedures begin
Who may not be able to join:
- You have previously been treated with a drug called cytarabine for a pre-existing blood or bone marrow condition
- You have a specific type of AML called acute promyelocytic leukemia (also known as M3 AML)
- AML has spread to your brain or spinal cord (central nervous system)
- You have tested positive for HIV
- You have taken certain strong or moderate medications that affect how drugs are broken down in the body (such as rifampin, carbamazepine, phenytoin, or St. John's Wort) within the 7 days before starting treatment
- You have eaten grapefruit, grapefruit products, Seville oranges (including certain marmalades), or starfruit within 3 days before starting treatment
- You have a more serious level of heart failure classified as New York Heart Association Class greater than 2 (confirm with trial site)
- You have a significant history of serious kidney, nerve, psychiatric, hormonal, immune, liver, heart, or other medical conditions that the doctor feels would make participation unsafe
- You have a long-term breathing condition that requires you to use oxygen continuously
- You have a condition that prevents your body from properly absorbing medications taken by mouth
- You have an uncontrolled, active infection (viral, bacterial, or fungal) that requires intravenous (IV) treatment
- You have a history of another cancer, unless it was an early-stage cancer of the breast or cervix, a skin cancer (basal cell or localised squamous cell), or a previous cancer that was fully removed or treated with the intention to cure
- Your white blood cell count is above a certain level (though a medication called hydroxyurea may be used to bring it down to meet this requirement — confirm with trial site)
- You are expected to have a bone marrow or stem cell transplant within 12 weeks of joining the trial
- You have a history of certain bone marrow or blood disorders, including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
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Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1: Number of Participants With Dose-limiting Toxicities; Phase 1: Maximum Observed Plasma Concentration (Cmax) of Venetoclax; Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax; Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to 24 Hours (AUC0-24) of Venetoclax; Phase 1: Maximum Observed Plasma Concentration (Cmax) of Cytarabine; Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Cytarabine; Phase 1: Area Under the Plasma Concentration-Time Curve Over Time From 0 to Last Measurable Concentration (AUCt) of Cytarabine; Overall...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.