Phase 2 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 have been diagnosed with a specific type of blood cancer called Acute Myeloid Leukemia (AML) — but not the subtype called acute promyelocytic leukemia (APL) — where the cancer has either a monocytic or monoblastic cell type, or a specific genetic change called a Ras pathway mutation
• People whose AML has come back or stopped responding to a previous treatment combining two specific drugs (a hypomethylating agent and venetoclax). Other treatments before or after that combination are allowed, including bone marrow/stem cell transplants. People whose blood cancer changed from a condition called CMML or MDS into AML after that same drug combination may also meet this criterion (confirm with trial site)
• People aged 18 or older
• People who are well enough to carry out basic daily activities, based on a standard medical fitness scale (a score of 0, 1, or 2 out of 4 on the ECOG scale)
• People whose kidneys are working well enough, as shown by a specific blood test result (confirm with trial site)
• People whose liver is working well enough, as shown by specific blood test results being within an acceptable range (confirm with trial site)
• Male participants who are not surgically sterile must agree to use contraception with their partner(s) during the study and for 90 days after the last dose, and must not donate sperm during that time. No contraception is required if the male participant has had a vasectomy confirmed by medical assessment, or if their partner is postmenopausal or has had certain surgical procedures to prevent pregnancy
• Female participants must either be postmenopausal (over 60 with no periods for 12 or more months without another medical explanation), have had certain surgical procedures that permanently prevent pregnancy, or use contraception throughout the study and for 6 months after the last dose if there is any chance of pregnancy
• People who are willing and able to sign a consent form agreeing to take part in the study before any study-related procedures begin

Who may not be able to join:

• People who have previously been treated with a drug called cladribine for AML
• People whose white blood cell count is too high (above a specific level), unless it can be brought down to an acceptable level using certain permitted medications or a procedure called leukapheresis (confirm with trial site)
• People whose AML has spread to the brain or spinal cord
• People who have an active, uncontrolled infection (bacterial, viral, or fungal) that is not improving with appropriate treatment. People whose infection is controlled with medication would not be automatically excluded
• People with other significant medical conditions that the trial doctor believes could make participation unsafe, including advanced heart failure, or serious kidney, nerve, psychiatric, hormonal, immune, liver, heart or blood-clotting conditions unrelated to the leukemia
• People whose heart electrical activity shows a specific measurement (QTc interval) above a certain level on an ECG (confirm with trial site)
• People who have had another type of cancer in the past 2 years, with some exceptions — such as certain early-stage or fully removed skin cancers, early-stage breast or cervical cancer that was treated, other cancers removed with the intent to cure, or prostate cancer managed with hormone therapy only
• People who are pregnant or currently breastfeeding
• People known to be HIV positive
• People known to have active hepatitis B or C infection with a detectable virus level. People who have been vaccinated against hepatitis B may still be eligible (confirm with trial site)

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