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 aged 18 or older
• People diagnosed with acute myeloid leukemia (AML) that has come back after treatment, shown by a certain level of leukemia cells in the bone marrow or blood
• People with AML that has not responded to treatment, having tried no more than 2 prior attempts to put the disease into remission
• People diagnosed with a bone marrow condition called MDS-EB-2 (a type of pre-leukemia with a high number of abnormal cells) that has not responded to, or has come back after, at least 4 cycles of a specific type of drug treatment (hypomethylating agents such as azacitidine or decitabine)
• People whose general health and ability to carry out daily activities meets a certain minimum level (confirm with trial site)
• People whose kidneys, liver, and heart are functioning at or above certain minimum levels as measured by blood tests and heart scans (confirm with trial site)
• People with a white blood cell count below a certain level at the start of treatment; a medication called hydroxyurea may be used to bring counts down beforehand
• People living with HIV who are on effective treatment and have had no detectable virus in their blood within the past 6 months
• People with a history of hepatitis B who have no detectable virus in their blood while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with no detectable virus in their blood
• People who have previously had leukemia spreading to the brain, as long as follow-up brain scans after treatment show the disease is not progressing
• Male participants who agree to avoid unprotected sex and not donate sperm from the start of the trial until 90 days after the last dose
• Female participants who are able to become pregnant, who have a negative blood pregnancy test within 7 days of starting the trial, and who agree to use barrier contraception from the start of the trial until 90 days after the last dose
• People who are able to understand and willing to sign a written consent form
• Men and women of all races and ethnic backgrounds are eligible for this trial

Who may not be able to join:

• People diagnosed with a specific type of leukemia called Acute Promyelocytic Leukemia (APL)
• People who currently have leukemia that has spread to the brain or spinal fluid
• People who have received chemotherapy, immunotherapy, radiation, or other experimental treatments within 2 weeks or 5 half-lives of the first dose (whichever is longer), with the exception of hydroxyurea
• People who have taken certain targeted therapy tablets called tyrosine kinase inhibitors (TKIs) within 2 weeks or 5 half-lives of the first dose (whichever is longer)
• People who are fewer than 100 days out from a bone marrow transplant from a donor
• People who have active graft-versus-host disease (a complication after a donor transplant), or who have not been off certain transplant-related medications for at least 28 days
• People who are still experiencing side effects from previous cancer treatment above a mild level (with the exception of hair loss)
• People who are currently taking part in another clinical trial involving an experimental treatment
• People currently taking certain medications that strongly affect how the body processes drugs (specifically strong CYP3A4 inducers or inhibitors), unless a suitable substitute medication is available (confirm with trial site)
• People taking a class of diabetes medications called gliptins (such as sitagliptin, saxagliptin, linagliptin, or similar)
• People with a history of a condition where blood pressure drops significantly when standing up, a resting blood pressure below a certain level, or poorly controlled high blood pressure
• People with moderate or severe heart failure affecting daily activities (confirm with trial site)
• People who have had another active cancer diagnosis within the past 2 years, with the exception of certain treated skin cancers, early-stage cervical or breast conditions, or low-grade prostate cancer
• People with a currently active, uncontrolled hepatitis B infection
• People with a currently active, uncontrolled hepatitis C infection
• People with serious uncontrolled ongoing illness such as active infection not responding to treatment, unstable heart conditions, uncontrolled irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• Women who are pregnant, as the study drug may harm an unborn baby
• Women who are breastfeeding

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