Early 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 1 month old up to and including 30 years old
• People diagnosed with a type of blood cancer called AML (acute myeloid leukemia) or myeloid sarcoma, as defined by 2022 medical classification guidelines, with or without the cancer spreading to other parts of the body
• People whose AML diagnosis is supported by one of the following: having 20% or more leukemia cells (blasts) in the bone marrow; having less than 20% blasts but with specific identified genetic changes in the cancer cells; having at least 1,000 leukemia cells per microlitre of blood when a bone marrow test cannot be done; or having a biopsy-confirmed myeloid sarcoma
• People who have received a specific first chemotherapy treatment (called DA10+GO, which combines three medicines: Cytarabine, Daunorubicin, and Gemtuzumab ozogamicin) as part of a standard treatment plan before joining this trial
• People who have received any number of treatments given directly into the spinal fluid (intrathecal treatments), regardless of the extent of cancer involvement in the nervous system
• People with a general health and activity level scored above 40 on a standard medical scale (Karnofsky scale for those 16 and older, Lansky scale for those under 16)
• People whose kidneys are working well enough, measured by a kidney filtration rate of 60 ml/min/1.73m² or higher
• People whose liver is working well enough, shown by specific blood test results within normal ranges (direct bilirubin below 2 mg/dL and liver enzyme ALT below a set level)
• People whose blood clotting is within an acceptable range (a test called INR at 1.5 or below)
• People whose heart is pumping strongly enough, shown by a heart scan taken within 14 days before the second round of treatment — specifically a pumping strength (ejection fraction) of 50% or higher, or an alternative heart measure (shortening fraction) of 24% or higher if the first measure is unavailable
• People diagnosed with a type of AML related to another blood condition (myelodysplasia-related AML), as long as it is not caused by a prior cancer treatment
• People (and/or their parents or legal guardians) who are able and willing to sign a written consent form

Who may not be able to join:

• People who have certain inherited conditions, including Fanconi anaemia, Shwachman-Diamond Syndrome, Telomere Disorders, or Down syndrome (constitutional trisomy 21, including mosaic forms)
• People with an inherited genetic condition that the treating doctor believes may increase the risk of serious side effects from AML treatment
• People whose AML developed as a result of a previous cancer treatment (therapy-related AML)
• People who have another cancer at the same time
• People diagnosed with a related but different blood cancer called juvenile myelomonocytic leukemia (JMML)
• People whose AML involves a specific genetic change called the Philadelphia chromosome
• People with a mixed type of acute leukemia (where cancer cells show features of more than one blood cell type)
• People with a specific subtype of AML called acute promyelocytic leukemia (APL)
• People whose AML involves a specific gene mutation called FLT3-ITD
• People who are currently pregnant (a pregnancy test will be required for females who could become pregnant)
• People who are breastfeeding and plan to continue doing so during the trial
• People who are sexually active and able to have children, where effective contraception has not been agreed to for the full duration of the trial

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