Phase 2 Leukaemia Trial, Recruiting

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

Who might be able to join this trial:

• You are 18 years of age or older (male or female).
• You have been diagnosed with a specific type of blood cancer called AML or a high-risk blood disorder called MDS, confirmed by genetic testing to have an IDH1 mutation.
• Your cancer has gone into complete or partial remission after your initial treatment.
• You are not able to have a stem cell transplant from a donor.
• You are reasonably active and able to care for yourself, with only limited restrictions on physical activity (confirm with trial site).
• You are willing and able to sign a consent form agreeing to take part.
• If you are a woman who could become pregnant, you must have been using contraception for at least one month before the screening visit and agree to continue using it throughout the study and for a set period afterward.
• Both women who could become pregnant and men whose partners could become pregnant must agree to use highly effective contraception from the time of signing the consent form until 180 days after the last dose of the study drug.

Who may not be able to join:

• You have previously been treated with a drug that targets the IDH1 mutation.
• You have been diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia (APL/M3).
• You have serious liver or kidney problems.
• You currently have an active infection or other serious health conditions.
• You have had major surgery within the 28 days before starting the study, or you are planning to have surgery during the study.
• You have been diagnosed with another cancer within the last 5 years, unless it was an early-stage cancer that was fully cured — such as certain skin cancers or early cervical changes (confirm with trial site, as the study doctor will assess this individually).
• You have serious heart or cardiovascular problems, such as significant heart failure, unstable chest pain, dangerous irregular heartbeat, a heart attack, or a stroke within the 3 months before joining the study.
• You have HIV, AIDS, active hepatitis B, hepatitis C, or a combination of hepatitis B and C infections.
• You have a known history of abusing psychoactive substances or drug addiction.
• You have any other serious physical or mental health condition, or abnormal test results, that the study doctor believes could put you at risk or affect the study results.
• You have difficulty swallowing, a bowel obstruction, or any other condition that could affect how you take or absorb the study drug.
• You have previously been treated with a combination of both drugs used in this trial at the same time (confirm with trial site).
• You have a known allergy to the study drug or any of its ingredients.

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