Phase 3 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:

• People who have already enrolled in a related study called APAL2020SC (NCT04726241) before joining this trial — this applies only to participants at sites in the USA, Canada, Australia, New Zealand, or Blood Cancer United territory.
• Children, adolescents, and young adults who are at least 29 days old and no older than 21 years at the time of joining.
• People who have a type of blood cancer called AML (acute myeloid leukemia) that does not have a specific genetic change called FLT3/ITD mutation — ideally confirmed at the current relapse, but a previous negative test result may also be accepted to avoid delaying treatment (confirm with trial site).
• People whose AML has come back for the second time and has not yet been treated for that relapse, and who are well enough to receive intensive chemotherapy — OR — people whose AML has come back for the first time and who, in their doctor's opinion, cannot safely receive more chemotherapy containing a group of drugs called anthracyclines.
• People who are in reasonably good general health, as measured by standard medical scoring tools (ECOG score of 0, 1, or 2, or equivalent).
• People who have recovered from the side effects of previous cancer treatments and have waited the required amount of time since their last treatment, including: at least 14 days since standard chemotherapy (some specific medications may be allowed closer to the start); no waiting period needed for certain chemotherapy given directly into the spinal fluid; at least 21 days since certain antibody-based treatments; at least 21 days since certain immune system drugs; at least 7–14 days since growth factor medications depending on the type; at least 14–84 days since radiation therapy depending on the type and location; at least 84 days since a bone marrow or stem cell transplant, with no active transplant-related complications; at least 42 days since donor immune cell infusions or other cell-based therapies.
• People who have stopped taking medications used to prevent or treat transplant rejection or graft-versus-host disease for at least 14 days before joining.
• People who have previously been treated with a drug called venetoclax are still considered eligible.
• People whose kidneys are working adequately, as measured by standard blood or urine tests.
• People whose liver is working adequately, based on standard blood test results — slightly higher liver readings may still be acceptable in certain circumstances (confirm with trial site).
• People with adequate heart function, with no history of heart failure requiring treatment, and no significant reduction in heart pumping strength shown on a heart scan.
• People (or their parent or guardian) who are able and willing to sign an informed consent form before any study procedures begin, in line with local laws.

Who may not be able to join:

• People who, in the investigator's opinion, may not be able to follow the study requirements.
• People with Down syndrome.
• People with specific types of leukemia called acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
• People with a particular type of leukemia affecting the brain and spinal fluid (called isolated CNS3 disease or symptomatic CNS3 disease).
• People who have a condition that prevents them from swallowing or absorbing oral medications (such as a condition called malabsorption syndrome).
• People who are currently taking another experimental drug not specified for this study.
• People with certain inherited bone marrow conditions, including Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known congenital bone marrow failure syndromes.
• People with a known allergy to any of the medications used in this trial.
• People with an active infection that is not under control at the time of joining the study.
• People with a known infection with hepatitis C, hepatitis B, or HIV.
• People who have taken certain medications that affect how the study drug is processed in the body — specifically strong or moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, or St. John's Wort — within 7 days before starting the study treatment.
• People who have eaten grapefruit, grapefruit products, Seville oranges (including certain marmalades), or starfruit within 3 days before starting study treatment.
• People with a known sensitivity to any ingredient in the study medications.
• People who are pregnant or breastfeeding.
• People of reproductive potential who are not willing to use highly effective contraception throughout the study and for a set period after the last dose of study treatment (the required period depends on which medications were received — confirm with trial site).
• Male participants who are not willing to use a condom during intercourse and to avoid fathering a child or donating sperm during and for a defined period after treatment (the required period depends on which medications were received — confirm with trial site).
• People with a history of a serious liver complication called veno-occlusive disease or sinusoidal obstruction syndrome (grade 3 or 4) will not be given one of the study drugs called gemtuzumab ozogamicin, though they may still be eligible for other parts of the study.
• People whose leukemia cells do not carry a marker called CD33 will not receive gemtuzumab ozogamicin, though they may still be eligible for other parts of the study.

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