ISRCTN12389567进行中（未招募）3 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
Cancer Research Clinical Trials Unit (CRCTU)0 个研究点目标入组 700 人开始时间: 2016年2月3日最近更新:
适应症
试验速览
- 阶段
- 3 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
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 02/09/2021:
- •Inclusion criteria for trial entry:
- •1. A diagnosis of AML/high risk myelodysplastic syndrome (MDS)/isolated myeloid sarcoma (either de novo or secondary)
- •2. Aged <18 years
- •3. No prior chemotherapy or biological therapy for AML other than that permitted in the protocol
- •4. Normal cardiac function (fractional shortening =28% or ejection fraction of 55%)
- •5. Fit for protocol chemotherapy
- •6. Documented negative pregnancy test for patients of childbearing potential
- •7. Patient agrees to use effective contraception (patients of childbearing potential)
- •8. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in the gemtuzumab ozogamicin dose finding study:
- •Centres must be formally activated in order to take part in the embedded dose escalation study (please contact the trial office for further information).
- •1. Patient meets the inclusion criteria for trial entry
- •2. Aged either:
- •2.1. =12 months for the major dose finding study
- •2.2. =12 weeks and <12 months
- •3. Normal renal function defined as calculated creatinine clearance =90 ml/min/1.73m² (calculated using the BNFc formula, or that in use locally)
- •4. Normal hepatic function defined as total bilirubin =2.5 x upper limit of normal (ULN) for age unless it is caused by leukaemic involvement, Gilbert’s syndrome, or a similar disorder
- •5. ALT or AST =10 x ULN for age
- •6. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for treatment with gemtuzumab ozogamicin for patients not participating in the gemtuzumab ozogamicin dose finding study or R2:
- •Centres must be formally activated to be able to deliver treatment with gemtuzumab ozogamicin (please contact the trial office for further information).
- •1. Patient meets the inclusion criteria for trial entry
- •2. Aged either:
- •2.1. =12 months
- •2.2. =12 weeks and <12 months
- •2.3. =28 days and and <12 weeks
- •3. Normal renal function defined as calculated creatinine clearance =90 ml/min/1.73m² (calculated using the BNFc formula, or that in use locally)
- •4. Normal hepatic function defined as total bilirubin =2.5 x upper limit of normal (ULN) for age unless it is caused by leukaemic involvement, Gilbert’s syndrome, or a similar disorder
- •5. ALT or AST =10 x ULN for age
- •6. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in R2 (once open to randomisation in the applicable age group):
- •1. Patient meets the inclusion criteria for trial entry
- •2. Aged either:
- •2.1. =12 months
- •2.2. =12 weeks and <12 months (once R2 open in patients aged =12 weeks and <12 months)
- •3. Normal renal function defined as calculated creatinine clearance =90 ml/min/1.73m² (calculated using the BNFc formula, or that in use locally)
- •4. Normal hepatic function defined as total bilirubin =2.5 x upper limit of normal (ULN) for age unless it is caused by leukaemic involvement, Gilbert’s syndrome, or a similar disorder
- •5. ALT or AST =10 x ULN for age
- •6. Written informed consent from the patient and/or parent/legal guardian
- •Inclusion criteria for participation in R4:
- •1. Patient meets the inclusion criteria for trial entry
- •2. Induction treatment as per MyeChild 01 protocol or treated with 1 or 2 courses of mitoxantrone & cytarabine ± treatment intensification with FLA-Ida off trial
- •3. Patient is in CR or CRi defined as <5% blasts confirmed by flow cytometry//molecular/FISH in a bone marrow aspirate taken
排除标准
- •Current participant exclusion criteria as of 02/09/2021:
- •1. Acute promyelocytic leukaemia (APL)
- •2. Myeloid leukaemia of Down Syndrome (ML DS)
- •3. Blast crisis of chronic myeloid leukaemia
- •4. Relapsed or refractory AML
- •5. Bone marrow failure syndromes
- •6. Prior anthracycline exposure which would inhibit the delivery of study anthracyclines
- •7. Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML/high risk MDS/isolated MS
- •8. Pregnant or lactating
- •Previous participant exclusion criteria:
- •1. Acute promyelocytic leukaemia (APL)
- •2. Myeloid leukaemia of Down Syndrome (ML DS)
- •3. Blast crisis of chronic myeloid leukaemia
- •4. Relapsed or refractory AML
- •5. Bone marrow failure syndromes
- •6. Prior anthracycline exposure which would inhibit the delivery of study anthracyclines
- •7. Concurrent treatment or administration of any other experimental drug or with any other biological therapy for AML
- •8. Pregnant or lactating females
研究者
相似试验
进行中（未招募）
1 期
Clinical Trial in Children with Acute Myeloid LeukaemiaEUCTR2014-005066-30-FRIVERSITY OF BIRMINGHAM700
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）
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