Phase 1 Leukaemia Trial, Recruiting
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:
- Adults aged 18 years or older.
- People with a confirmed diagnosis of relapsed or refractory acute myeloid leukemia (a blood cancer that has come back or stopped responding to treatment), or related blood/bone marrow conditions (MDS/AML or MDS with excess blasts), who are unable to tolerate or are considered unsuitable for other available treatments.
- People with a white blood cell count at or below 25,000 per microliter at the time of screening.
- People with a general health and activity level rated at 2 or below on a standard medical scale (meaning able to carry out basic self-care, even if unable to work) (confirm with trial site).
- People who weigh at least 40 kilograms.
- Women who could potentially become pregnant must have a negative blood pregnancy test at screening, agree not to try to become pregnant, not harvest eggs, and not breastfeed during the study, and must agree to use specific contraception methods or avoid intercourse.
- Men must agree to use specific contraception methods and not try to father a child or donate sperm during the study.
- People who are willing and able to give written consent and follow the requirements of the trial.
Who may not be able to join:
- People who have received a donor stem cell transplant within the past 6 months, their own stem cell transplant within the past 3 months, any anti-cancer treatment within the past 2 weeks, or radiation therapy within the past 4 weeks.
- People with certain other medical conditions, including another active cancer, a heart attack within the past 6 months, significant heart failure with symptoms, an uncontrolled active infection, or a history of a blood clot in an artery within the past 6 months.
- People whose test results fall outside required ranges, including reduced heart pumping function, an abnormal heart rhythm measurement, liver enzyme levels more than 3 times the normal upper limit, total bilirubin more than 1.5 times the normal upper limit, or reduced kidney function below a specific threshold (confirm with trial site for exact values).
- People who are HIV positive or have active hepatitis B and/or C.
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.
Contact this trial
Principal Investigator: Sanjay Aggarwal, MD, Apollo Therapeutics
Phone: 781-479-2267
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Incidence of Treatment Emergent Adverse Events [Safety]; Incidence of Dose Limiting Toxicities [Tolerability]; Determine Recommended Phase 2 Dose (RP2D)/Recommended dose range (RDR) levels of APL-4098 alone, in combination with azacitidine, and in combination with azacitidine plus venetoclax.; Assess the Pharmacokinetics of APL-4098; Assess the Pharmacokinetics of APL-4098; Assess the Pharmacokinetics of APL-4098
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.