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 a confirmed diagnosis (proven by tissue testing) of one of the following blood cancers: AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), a treatment-related myeloid cancer (tMDS/AML), Myeloid Sarcoma, or Acute Undifferentiated Leukemia — including cases that are new, have come back, or developed from another condition.
• People whose blood cancer developed from a hereditary (genetic) bone marrow condition may also be eligible, and will be placed into different study groups depending on whether their inherited condition is associated with a standard or higher risk of treatment side effects (confirm with trial site).
• People who are scheduled to receive a stem cell transplant from a donor — all donor types, graft sources, conditioning regimens, and GVHD prevention regimens are permitted.
• Enrollment must happen between 40 days before and 1 day before the stem cell infusion.
• People who, after the transplant and before treatment begins, have no detectable signs of cancer remaining (MRD-negative remission, tested by a specific lab method).
• People of any prior treatment history — there are no restrictions on previous treatments.
• People aged 1 to 39 years old.
• People with a general health/functioning score showing they are reasonably active and able to carry out self-care (ECOG score of 2 or below, or equivalent scale score of 60% or above).
• People whose organ function meets the institution's standard requirements for a donor stem cell transplant.
• People living with HIV whose virus is undetectable on effective treatment within the past 6 months, provided their HIV medications do not interact with the study drugs.
• People with chronic hepatitis B whose virus is undetectable on suppressive therapy, provided those medications do not interact with the study drugs.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load, provided their medications do not interact with the study drugs.
• People with another cancer that is currently in remission.
• People with a history of heart problems whose heart function is assessed as Class 2B or better using a standard heart function classification scale.
• People who are able to use adequate contraception (hormonal, barrier methods, or abstinence) throughout the study and for 4 months after finishing the study drug decitabine — this applies to people who could become pregnant and to men, because one of the study drugs (decitabine) is known to be harmful to a developing baby and the effects of filgrastim on a developing baby are unknown.
• People who are able to understand and sign a written consent form agreeing to take part.

Who may not be able to join:

• People who still have significant ongoing side effects (above Grade 2 severity) from previous cancer treatments, except for low blood counts caused by bone marrow suppression.
• People who are enrolled in another study that does not allow them to start maintenance therapy.
• People who have had a serious allergic reaction to drugs chemically similar to decitabine or filgrastim.
• People with a serious illness or infection that is not currently under control.
• People who would not be able to attend clinic visits for at least 7 months after starting the study treatment.
• People whose cancer has a specific gene change called FLT3/ITD, as a different type of maintenance therapy is generally considered more appropriate for them — unless their cancer also has a co-occurring NUP98 mutation, in which case eligibility may be reconsidered (confirm with trial site).
• People who currently have another active cancer (not in remission).

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