Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older at the time of signing the consent form
• People who are willing and able to attend study visits and follow the study requirements
• People who have been diagnosed with AML (a type of blood cancer) that has come back after treatment (relapsed) or has not responded to treatment (refractory), including people whose cancer appeared to be in remission but where disease markers have reappeared in testing
• People whose AML did not respond to at least one round of strong chemotherapy, OR did not respond to at least two cycles of lower-intensity treatments (such as certain drug combinations including hypomethylating agents, low-dose chemotherapy, or venetoclax-based combinations), as applicable to their treatment history
• People whose AML has specific genetic mutations — either both IDH2 and FLT3 mutations, or both IDH1 and FLT3 mutations, or a FLT3 mutation that responds to a drug called gilteritinib — this includes people who developed one of these mutations while already being treated with a related targeted therapy
• People who have had these genetic mutations confirmed by approved laboratory testing of bone marrow or blood within the past 30 days
• People with a performance status score of 0 to 3 on a standard medical scale that measures how much a person's illness affects their daily activities (confirm with trial site)
• People whose kidneys are functioning at an adequate level, based on blood or urine test results meeting specific thresholds
• People whose liver is functioning at an adequate level, based on blood test results meeting specific thresholds
• People who have previously had a stem cell transplant (either from their own cells or from a donor) for AML
• Women of childbearing potential who have had a negative pregnancy test within 7 days of starting treatment and who agree to use two accepted methods of contraception during treatment and for at least 6 months after the last dose
• Male participants with female partners who could become pregnant, who agree to use contraception during treatment and for at least 6 months after the last dose

Who may not be able to join:

• People diagnosed with a specific subtype of blood cancer called acute promyelocytic leukemia (APL)
• People currently taking any other experimental cancer treatments
• People with an active, uncontrolled infection (fungal, bacterial, or viral)
• People with any other medical condition that the treating doctor believes would make participation unsafe or unsuitable
• People experiencing severe, immediately life-threatening complications of leukemia, such as uncontrolled bleeding, pneumonia with low oxygen levels, severe shock, or a serious blood clotting disorder
• People who have had significant heart problems within the 6 months before starting the study, including severe heart failure, a heart attack, or a stroke
• People whose heart pumping function (measured by a heart scan) is below a certain level, based on a scan done within 28 days before starting treatment
• People who have difficulty swallowing or have conditions that prevent them from properly absorbing tablets or capsules taken by mouth
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy
• People with a certain type of abnormal heart rhythm reading (called a prolonged QTc interval) on an ECG, or other risk factors for dangerous heart rhythm problems, unless a specific exception is approved by the lead study doctor
• People with active graft-versus-host disease (a complication that can occur after a donor stem cell transplant) — however, people whose graft-versus-host disease affects only the skin and is controlled with topical creams may still be eligible
• People who are pregnant or currently breastfeeding

Important: Always verify eligibility with the trial site directly before applying.