EUCTR2014-005066-30-FR进行中（未招募）1 期
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 - MYECHILD01
IVERSITY OF BIRMINGHAM0 个研究点目标入组 700 人开始时间: 2016年4月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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 R1 randomisation
- •. Diagnosis of AML/high risk MDS (>10% blasts in the bone marrow)/isolated MS
- •(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 defined as 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 child bearing potential)
- •. Written informed consent from the patient and/or parent/legal guardian
- •Patients with reproductive potential must agree to use effective contraception during the period of therapy. Both men and women of childbearing potential should be advised to use effective contraception to avoid pregnancy up to 12 months after the last dose of study treatment. Effective contraceptive methods include hormonal and barrier contraception etc.
- •Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:
- •Centres must be formally activated in order to be take part in the embedded dose escalation study. Please contact the trial office for further information.
- •. Patient meets the inclusion criteria for trial entry
- •o .12 months for the major dose finding study
- •o . 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 Gilbertfs syndrome or similar disorder
- •. ALT or AST .10 x ULN for age
- •. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in R2 (randomisation not yet open)
- •. Patient meets the inclusion criteria for trial entry (section 4.1.1)
- •. Age .12 weeks
- •. 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 and not due to leukaemic involvement or Gilbertfs syndrome or similar disorder
- •. ALT or AST .10 x ULN for age
- •. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in R3
- •. Patient meets the inclusion criteria for trial entry (section 4.1.1)
- •. Induction treatment as per MyeChild 01 protocol or treated with 2 courses of mitoxantrone & cytarabine off trial
- •. MRD response (performed in MyeChild 01 centralised laboratories, see national MyeChild 01 Laboratory Manual):
- •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
- •o 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 mee
排除标准
- •Exclusion criteria for all randomisations
- •Acute Promyelocytic Leukaemia
- •Myeloid Leukaemia of Down Syndrome
- •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
相似试验
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 ChemotherapyAcute Myeloid LeukaemiaMedDRA version: 18.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-005066-30-GBniversity of Birmingham700
进行中（未招募）
3 期
MyeChild 01: Treating children with acute myeloid leukaemiaAcute myeloid leukaemiaAcute megakaryoblastic leukaemiaCancerISRCTN12389567Cancer Research Clinical Trials Unit (CRCTU)700
进行中（未招募）
1 期
Study on the post surgery treatment of patients with curative surgical resection due to colon rectal tumor.High-risk stage III colon cancerMedDRA version: 21.0Level: PTClassification code 10038098Term: Rectosigmoid cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001491-29-ITICANCER640
进行中（未招募）
1 期
A Phase III, Randomised, international trial comparing mFOLFIRINOX triplet chemotherapy to mFOLFOX for high-risk stage III colon cancer in adjuvant setting - IROCASHigh-risk stage III colon cancer in adjuvant settingMedDRA version: 19.0Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001491-29-FRICANCER640
招募中
3 期
Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients.Fallopian tube CancerPeritoneal CancerCancer - Ovarian and primary peritonealOvarian CancerACTRN12618000498291The University of Sydney110