Ma-Spore ALL 2010 Study
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
The overall objective of this study is to continue to improve the cure rate of childhood acute lymphoblastic leukemia (ALL) in Singapore and Malaysia in the context of a multi-centre cooperative trial using a risk-stratified therapy based primarily on early response to therapy utilizing a simplified minimal residual disease (MRD-lite) platform.
详细描述
The study was designed on the premise that a risk classification strategy combining clinical and genetic presenting features with molecular assessment of MRD should reduce both treatment-related toxicities and relapse risk.
The patient will be assigned to one of the 3 risk groups depending on his/her response to the treatment and special laboratory tests. There are no experimental drugs in this study. All the drugs used are standard established treatment for childhood ALL for the last 30 years. The difference in treatment is by changes in the frequency and dose of the chemotherapy drugs.
The overall study treatment lasts for about 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of non-Burkitt B-lineage ALL
- •1 to 17 years of age (before 18th birthday)
- •Renal function within normal range for age
- •Liver function within normal range for age
- •Able to participate in the full 2 years of treatment
排除标准
- •Age less than one year or age greater than/equals to 18 years
- •Previous treatment with cytotoxic agents or high-dose steroids
- •Mixed phenotype acute leukemia (MPAL)
- •ALL as secondary malignancy
- •Abnormal renal or liver function
- •Doubtful compliance or unable to afford full course of therapy
研究组 & 干预措施
High risk (HR)
干预措施: Prednisolone (Drug)
High risk (HR)
干预措施: Thioguanine (Drug)
High risk (HR)
干预措施: Fludarabine (Drug)
Standard Risk (SR)
干预措施: L-Asparaginase (Drug)
Standard Risk (SR)
干预措施: Vincristine (Drug)
Standard Risk (SR)
干预措施: Methotrexate (Drug)
Standard Risk (SR)
干预措施: Cyclophosphamide (Drug)
Standard Risk (SR)
干预措施: Cytarabine (Drug)
Standard Risk (SR)
干预措施: 6-Mercaptopurine (Drug)
Standard Risk (SR)
干预措施: Thioguanine (Drug)
Intermediate Risk (IR)
干预措施: Thioguanine (Drug)
Standard Risk (SR)
干预措施: Prednisolone (Drug)
Standard Risk (SR)
干预措施: Dexamethasone (Drug)
Intermediate Risk (IR)
干预措施: Prednisolone (Drug)
Intermediate Risk (IR)
干预措施: Dexamethasone (Drug)
Intermediate Risk (IR)
干预措施: L-Asparaginase (Drug)
Intermediate Risk (IR)
干预措施: Vincristine (Drug)
Intermediate Risk (IR)
干预措施: Methotrexate (Drug)
Intermediate Risk (IR)
干预措施: Doxorubicin (Drug)
Intermediate Risk (IR)
干预措施: Cyclophosphamide (Drug)
Intermediate Risk (IR)
干预措施: Cytarabine (Drug)
Intermediate Risk (IR)
干预措施: 6-Mercaptopurine (Drug)
High risk (HR)
干预措施: Dexamethasone (Drug)
High risk (HR)
干预措施: L-Asparaginase (Drug)
High risk (HR)
干预措施: Vincristine (Drug)
High risk (HR)
干预措施: Methotrexate (Drug)
High risk (HR)
干预措施: Daunorubicin (Drug)
High risk (HR)
干预措施: Doxorubicin (Drug)
High risk (HR)
干预措施: Cyclophosphamide (Drug)
High risk (HR)
干预措施: Cytarabine (Drug)
High risk (HR)
干预措施: 6-Mercaptopurine (Drug)
High risk (HR)
干预措施: Imatinib (Drug)
结局指标
主要结局
Event-free survival (EFS)
时间窗: 5 years
EFS was estimated from time of diagnosis to time of first event or of patient's last follow-up. Failure to achieve complete remission (CR), relapse, death in continuous remission from whatever cause, secondary leukemia and abandonment (absence from scheduled therapy for more than 6 weeks) were considered as events.
Overall survival (OS)
时间窗: 5 years
OS was determined from diagnosis to time of death from any cause.
Minimal residual disease (MRD) measurement
时间窗: At time point of Day 33, week 8 and week 12
次要结局
- Number of participants with chemotherapy-related adverse events as assessed by CTCAE version 4.0(Through study completion, an average of 2 years)
- Dose intensity of chemotherapy during various phases of therapy(Through study completion, an average of 2 years)