This phase III trial is comparing two induction chemotherapy treatments in children with Acute Myeloid Leukaemia (AML).
This trial is treating patients with acute myeloid leukaemia (AML).
This is a systemic therapy trial.
You may be able to join this trial if:
- You have been diagnosed with cancer, but have not received any treatment.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
- You have previously been treated (or are currently being treated) on a clinical trial.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia - Incorporating an Embedded Dose Finding Study for Gemtuzumab Ozogamicin in Combination With Induction Chemotherapy
Other Non-Commercial Sponsor
University of Birmingham
Summary
This trial is comparing two induction chemotherapy regimens: mitoxantrone and cytarabine (current standard treatment) with liposomal daunorubicin and cytarabine. Patients responding well to induction chemotherapy are eligible for a randomisation of two consolidation regimens: high dose cytarabine (current standard treatment) or fludarabine and cytarabine (FLA); a regimen commonly used in patients with relapsed disease, testing whether FLA is more effective in front line therapy than standard consolidation treatment. Patients with cytogenetic features associated with a higher risk of relapse and those responding sub-optimally to induction treatment are candidates for haemopoietic stem cell transplant (HSCT) and are eligible for a randomisation comparing two HSCT conditioning regimens: myeloablative conditioning (MAC) (current UNited Kingdom (UK) standard) or reduced intensity conditioning (RIC). This trial also incorporates a dose finding study for gemtuzumab ozogamicin.
Recruiting Hospitals Read More