OncoMatch/Clinical Trials/NCT02724163
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Is NCT02724163 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for acute myeloid leukaemia.
Treatment: Gemtuzumab ozogamicin · Liposomal daunorubicin · Mitoxantrone · Fludarabine · Cytarabine · Busulfan · Cyclophosphamide — The main purpose of this study is : 1. To establish which number of doses of gemtuzumab ozogamicin (up to a maximum of 3 doses) is tolerated and can be safety delivered in combination with cytarabine plus mitoxantrone or liposomal daunorubicin in induction 2. To compare mitoxantrone (anthracenedione) \& cytarabine with liposomal daunorubicin (anthracycline) \& cytarabine as induction therapy. (Randomisation 1 (R1) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug.) 3. To compare a single dose of gemtuzumab ozogamicin with the optimum tolerated number of doses of gemtuzumab ozogamicin (identified by the dose-finding study) when combined with induction chemotherapy. 4. To compare two consolidation regimens: high dose cytarabine (HD Ara-C) and fludarabine \& cytarabine (FLA) in standard risk patients. 5. To compare the toxicity and effectiveness of two haemopoietic stem cell transplant (HSCT) conditioning regimens of different intensity: conventional myeloablative conditioning (MAC) with busulfan/cyclophosphamide and reduced intensity conditioning (RIC) with fludarabine/busulfan.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Cannot have received: chemotherapy or biological therapy for AML/high risk MDS/isolated MS
Exception: other than that permitted in the protocol
No prior chemotherapy or biological therapy for AML/high risk MDS/isolated MS other than that permitted in the protocol.
Cannot have received: anthracycline
Exception: prior anthracycline exposure which would inhibit the delivery of study anthracyclines
Prior anthracycline exposure which would inhibit the delivery of study anthracyclines.
Lab requirements
Kidney function
Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2.
Liver function
Normal hepatic function defined as total bilirubin ≤2.5 upper limit of normal (ULN) for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar disorder. Alanine transaminase (ALT) or aspartate transaminase (AST) ≤10 x ULN for age.
Cardiac function
Normal cardiac function defined as fractional shortening ≥28% or ejection fraction ≥55%.
Normal cardiac function defined as fractional shortening ≥28% or ejection fraction ≥55%. Normal renal function defined as calculated creatinine clearance ≥90ml/min/1.73m2. Normal hepatic function defined as total bilirubin ≤2.5 upper limit of normal (ULN) for age unless it is caused by leukaemic involvement or Gilbert's syndrome or similar disorder. Alanine transaminase (ALT) or aspartate transaminase (AST) ≤10 x ULN for age.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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