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International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia

Study acronym: Myechild01
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 68 of 68 sites
    v11
  2. Study sites: 67 to 68v10
  3. Study sites: 59 to 67
    • Eligibility criteria expanded, about 117 words
    • Study description expanded, about 23 words
    v9
  4. Study sites: 21 to 59v8
  5. Re-verified, no change to tracked fieldsv7
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  1. Site details revised at 2 of 21 sitesv6
  2. Study sites: 20 to 21v5
  3. Study sites: 19 to 20v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites revised (19)
    v3
  5. Start date: Mar 2016 to Apr 2016
    • Secondary endpoints: details revised at 2 of 20 entries
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02724163
Lead Sponsor University of Birmingham
Collaborators: Assistance Publique - Hôpitaux de Paris, Cancer Research UK, National Cancer Institute, France, Pfizer
Conditions
(from sponsor)		 Acute Myeloid Leukaemia
Related terms Leukemia, Myeloid, Acute, Neoplasm, Residual
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov