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 given written consent to participate in the study
• People who have been newly diagnosed with a specific type of acute myeloid leukaemia (AML) — for the Phase I part (MODULE), this includes certain genetic subtypes (t(8;21), inv(16)/t(16;16), FLT3-ITD, or FLT3-TKD); for the Phase II MAGNOLIA part, only the t(8;21) or inv(16)/t(16;16) subtypes; for the Phase II MAGMA part, only the FLT3-ITD or FLT3-TKD subtypes without the CBF gene changes listed above (confirm with trial site)
• People aged 18 to 75 years for the Phase I part (MODULE), or aged 18 to 70 years for the Phase II parts (MAGMA and MAGNOLIA)
• People with a general health and activity level rated as 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People with a life expectancy of more than 14 days
• People whose liver and kidney function fall within acceptable ranges as determined by blood tests (confirm with trial site)
• People whose white blood cell count is below a certain level — limited use of specific medications (hydroxyurea and/or low-dose cytarabine) may be permitted beforehand to bring this count to the required level (confirm with trial site)

Who may not be able to join:

• People who have previously received cancer treatment for AML, other than limited emergency use of hydroxyurea and/or low-dose cytarabine as described above
• People who have previously been treated with a class of cancer drugs called anthracyclines
• People whose AML has spread to the central nervous system (the brain and spinal cord)
• People whose AML exists only outside the bone marrow, with no bone marrow involvement
• People with an infection that is not currently under control
• People whose AML developed following a blood disorder called myelodysplastic syndrome (MDS) that was previously treated with certain chemotherapy drugs (such as azacytidine or decitabine)
• People who have taken an experimental (unapproved) medication within the past 30 days, or within 5 half-lives of that drug — whichever is the longer period
• People who have previously been treated with a FLT3 inhibitor drug (such as midostaurin, quizartinib, or sorafenib)
• People currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A4/5 inducers), unless those medications can be stopped or swapped before joining the trial
• People with another serious or uncontrolled medical condition that could affect their ability to safely participate (confirm with trial site)
• People with a stomach or bowel condition that could significantly affect how the body absorbs the study drug midostaurin
• People with a confirmed diagnosis of HIV
• People with active viral hepatitis, unless specific test results show the infection has cleared — people with certain hepatitis B or C situations may still be eligible depending on test results (confirm with trial site)
• People with certain heart conditions, including: a heart attack, chest pain (angina), or heart bypass surgery within the past 6 months; certain uncontrolled heart rhythm problems; uncontrolled heart failure; a pumping function of the heart below 50%; or poorly controlled high blood pressure
• People who are pregnant or breastfeeding
• Women who are physically capable of becoming pregnant, unless they meet at least one of the following: they are post-menopausal; they have had both ovaries surgically removed; they have a negative pregnancy test within 7 days before starting the study drug; they use a highly effective contraception method (Pearl Index below 1%, such as implants, injections, the pill, or an intrauterine device) combined with a barrier method (such as a condom) from the start of treatment until at least 7 months after the last dose of one study drug (gemtuzumab ozogamicin) or 4 months after the last dose of another (midostaurin), whichever is longer; they are completely abstinent from sexual activity; or their sexual partner has had a vasectomy
• Sexually active males who are unwilling to use a condom during intercourse throughout treatment and for at least 4 months after the last dose, and who are unwilling to avoid fathering a child during this time — this includes men who have had a vasectomy and men whose partner is male
• People who are unwilling or unable to follow the study requirements
• People with a known allergy or sensitivity to any of the study drugs (midostaurin, gemtuzumab ozogamicin, cytarabine, or daunorubicin) or their ingredients

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