International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Status:
Recruiting
Trial end date:
2032-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Birmingham
Collaborators:
Assistance Publique - Hôpitaux de Paris Cancer Research UK National Cancer Institute, France Pfizer