International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
Condition: Acute Myeloid Leukaemia · Sponsor: University of Birmingham
About this study
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.
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (68)
| Women and Children's Hospital Adelaide | Adelaide, Australia | — |
| Queensland Children's Hospital | Brisbane, Australia | — |
| Monash Children's Hospital | Melbourne, Australia | — |
| Royal Childrens Hospital | Melbourne, Australia | — |
| John Hunter Children's Hopsital | New Lambton Heights, Australia | — |
| Perth Children's Hospital | Perth, Australia | — |
| Sydney Children's Hospital | Sydney, Australia | — |
| The Childrens Hospital At Westmead | Westmead, Australia | — |
| Centre Hospitalier Universitaire Amiens - Picardie | Amiens, France | — |
| Centre Hospitalier Universitaire D'angers | Angers, France | — |
| Centre Hospitalier Regional Universitaire Besancon - Hopital Jean Minjoz | Besançon, France | — |
| Centre Hospitalier Universitaire De Bordeaux - Hopital Pellegrin | Bordeaux, France | — |
+ 56 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02724163