EUCTR2014-005066-30-GB进行中（未招募）不适用
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 - MyeChild 01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria for trial entry and Randomisation 1 (induction chemotherapy randomisation):
- •- A diagnosis of AML/high risk myelodysplastic syndrome (MDS)/isolated myeloid sarcoma (either de novo or secondary)
- •- Age <18 years
- •- No prior chemotherapy or biological therapy for AML other than that permitted in the protocol
- •- Normal cardiac function (fractional shortening =28% or ejection fraction =55%)
- •- Fit for protocol chemotherapy
- •- Documented negative pregnancy test for female patients of childbearing potential
- •- Patient agrees to use effective contraception (patients of childbearing potential)
- •- Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:
- •- Patients meets the inclusion criteria for trial entry
- •- Age =12 months for the major dose finding study
- •- Age = 12 weeks and <12 months for the minor dose finding study
- •- Karnofsky or Lansky performance score of =50
- •- 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
- •- ALT or AST =10 x ULN for age
- •- Written informed consent from the patient or parent/legal guardian
- •Inclusion criteria for participation in R3:
- •- Patient meets the inclusion criteria for trial entry
- •- Induction treatment as per MyeChild 01 protocol or treated with 2 courses of mitoxantrone & cytarabine off trial
- •- Minimal residual disease (MRD) response (performed in MyeChild 01 centralised laboratories, see national MyeChild 01 Laboratory Manual):
- •1) Patients with good risk cytogenetics/molecular genetics and a MRD level <0.1% by flow after course 2, or a decrease in transcript levels of >3 logs after course 2 for those with an informative molecular marker but without an informative marker of sufficient sensitivity for flow MRD monitoring
- •2) Patients with intermediate risk cytogenetics/molecular genetics with a MRD level <0.1% by flow after course 1 and course 2, or a decrease in transcript levels of >3 logs after course 1 and course 2 for those with an informative molecular marker, but without an informative marker of sufficient sensitivity for flow MRD monitoring
- •- Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in R4:
- •- Patient meets the eligibility criteria for trial entry
- •- Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of mitoxantrone & cytarabine ± treatment intensification with FLA-Ida off trial
- •- Patient is in CR or CRi defined as <5% blasts confirmed by flow cytometry//molecular/FISH in a bone marrow aspirate taken within 6 weeks prior to randomisation to R4.
- •- Patient meets one of the following criteria and is a candidate for haemopoeitic stem cell transplant (HSCT) as per the protocol:
- •1) High risk after course 1 (all patients with poor risk cytogenetics and patients with intermediate risk cytogenetics who fail to achieve CR/CRi)
- •2) Intermediate risk cytogenetics with MRD >0.1% after course 1 and 2 measured by flow. If no flow MRD marker of sufficient sensitivity is identified, a molecular MRD marker with a sensitivity of >0.1% may be used
- •3) Good risk cytogenetics with flow MRD >0.1% confirmed by a decrease in molecular MRD of <3 logs or rising transcript levels after co
排除标准
- •Exclusion criteria for all randomisations
- •- Acute promyelocytic leukaemia (APL)
- •- Myeloid leukaemia of Down Syndrome (ML DS)
- •- Blast crisis of chronic myeloid leukaemia
- •- Relapsed or refractory AML
- •- Bone marrow failure syndromes
- •- Prior anthracycline exposure which would inhibit the delivery of study anthracyclines
- •- Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML
- •- Pregnant or lactating females
研究者
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