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:

• Adults over 18 years of age
• People who are generally able to carry out daily activities with little or no limitation (confirmed by a standard medical assessment called ECOG performance status below 2)
• People whose disease has a specific genetic change called IDH1-R132 mutation, confirmed by a local laboratory test (other similar rare variants may be considered after discussion with the trial doctor)
• People with a blood cancer called AML that has come back or stopped responding to treatment, or who have newly diagnosed AML and are not suitable for standard intensive chemotherapy
• People with certain high-risk blood or bone marrow conditions (high-risk MDS, MDS/MPN, or MPN) that have not responded to standard treatment — eligibility to be confirmed with the trial doctor
• People whose liver is functioning well enough, based on standard blood test results (unless any abnormality is caused by the underlying blood cancer)
• People whose kidneys are functioning well enough, based on a standard calculation of kidney filtration rate
• People who are willing and able to give informed consent to participate
• People who have waited at least 7 days since their last cancer treatment before starting the trial (except in cases of rapidly progressing disease)
• Male participants who agree to use contraception and avoid sperm donation from the start of the trial until 90 days after the last dose of study medication

Who may not be able to join:

• People who have a known allergy or sensitivity to either of the study drugs, ivosidenib or venetoclax
• People who have previously received ivosidenib or venetoclax
• People who have another serious uncontrolled medical condition, active infection, significant abnormal blood results, or a mental health condition that could put them at unacceptable risk during the trial
• People who are currently taking other chemotherapy or anti-cancer treatments (with limited exceptions, such as certain drugs used to control rapidly growing disease or treatment directed into the fluid around the spine — confirm specifics with the trial site)
• People who have taken certain strong medications that affect how the body breaks down drugs (including carbamazepine, phenytoin, rifampin, rifabutin, or St. John's Wort) within 3 days before starting the trial
• People who have active graft-versus-host disease following a stem cell transplant (those with well-controlled, non-active graft-versus-host disease on ongoing treatment may be considered after discussion with the trial doctor)
• People with serious conditions affecting the stomach or digestive system that could interfere with absorbing oral medications
• People currently receiving treatment for another active cancer
• People with a particular type of heart rhythm abnormality (a prolonged QTcF interval above 450 milliseconds on an ECG), though some related heart conditions may be considered after discussion with the trial doctor
• People with active hepatitis B, hepatitis C, or HIV infection
• People with a white blood cell count above a certain level (25 x 10⁹/L), unless medication has been used to bring it down before assessment
• Women who are pregnant, breastfeeding, or who are of childbearing potential and have a positive pregnancy test
• Women of childbearing potential who are not willing to use an effective form of contraception (such as hormonal contraception, an IUD, or a double barrier method) throughout the trial

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