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:
- People who are able to show they understand the trial and have voluntarily signed a consent form
- People aged 18 years or older
- People who have been diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), whose disease has come back or has not responded to previous treatment, and for whom standard treatment options have been tried or are not suitable
- People whose general health and ability to carry out daily activities meets a certain minimum level (called ECOG performance status of 2 or lower), and who are expected to live at least 6 weeks
- People whose kidneys, liver, and other organs are functioning well enough to meet the trial's specific blood test requirements (confirm with trial site)
- Women who could become pregnant must not be pregnant at the start of the trial, and must agree to either avoid sexual intercourse or use highly effective contraception during the trial and for up to 3 months after the last dose of the study drug
- Men who are sexually active with a woman who could become pregnant must agree to use a barrier method of contraception (such as a condom) during the trial and for up to 3 months after the last dose of the study drug
Who may not be able to join:
- People who have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia
- People with a very high white blood cell count above a certain level (confirm with trial site)
- People who have received cancer chemotherapy (other than a drug called hydroxyurea) within 2 weeks before starting the study drug
- People who have had a stem cell transplant within the 3 months before screening, or who have active graft-versus-host disease requiring more than topical treatments, or who have been on certain immune-suppressing medications within a specified period before screening (confirm details with trial site)
- People experiencing severe, immediately life-threatening complications from leukemia, such as uncontrolled bleeding, pneumonia with low oxygen levels or shock, or a serious blood clotting condition
- People who still have significant side effects (grade 2 or higher) from a previous cancer treatment
- People with an active, uncontrolled infection caused by fungi, bacteria, mycobacteria, or a virus
- People with a significant heart condition
- People who have difficulty swallowing, or have a condition that affects how the body absorbs medication taken by mouth
- People with any other medical condition that the trial doctor believes could interfere with the trial or create a risk to the person's wellbeing
- Women who are pregnant or breastfeeding
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: Zung Thai, MD, Edgewood Oncology Inc.
Phone: 415-225-9338
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
Primary endpoints
Incidence of dose-limiting toxicities (DLTs); Number of participants with non-serious AEs and serious AEs (SAEs); Number of participants with laboratory abnormalities and/or AEs; Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs; Number of participants with echocardiogram (ECHO) abnormalities and/or AEs; Number of participants with vital sign abnormalities and/or AEs; Number of participants with physical examination abnormalities and/or AEs; Maximum tolerated dose (MTD); Recommended Phase 2 dose (RP2D)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.