A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 8
- 主要终点
- Minimal Residual Disease (MRD).
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.
详细描述
The study compares the effectiveness of two doses of cytarabine combined with set doses of daunomycin and etoposide as an initial course of chemotherapy to eliminate minimal residual disease. Subsequent therapy is tailored according to cytogenetic risk features, assessments of minimal residual disease, and availability of a suitable donor for bone marrow transplant. Patients with higher risk disease features are given more intense therapy. For higher risk groups, transplant is given to patients with suitable donors.
Secondary objectives include:
- To assess the prognostic value of biological markers in childhood Acute Myeloid leukemia (AML).
- To compare the amounts of leukemia cells in the blood and bone marrow to study minimal residual disease(MRD).
- To relate non-invasive cardiac evaluation with health-related quality of life in AML patients treated with cardiotoxic therapy during and following therapy.
Detailed Description of Treatment Plan Induction I Patients will be randomly assigned to receive induction therapy that consists of daunomycin, etoposide, and high-dose or low-dose cytarabine.
High-Dose Cytarabine (HDAC) arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical staining; myelodysplasia; or biphenotypic leukemia.
- •Age less than or equal to 21 years at time of study entry.
- •No prior therapy for this malignancy (patients with secondary AML following treatment of primary malignancy are eligible) except for one dose of intrathecal therapy.
- •Negative pregnancy test
- •Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
排除标准
- •Positive pregnancy test
- •Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
研究组 & 干预措施
HDAC (High-Dose Cytarabine)
Since limited characters are allowed in this passage, please see detailed Description for HDAC.
干预措施: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone (Drug)
LDAC (Low-Dose Cytarabine)
Since limited characters are allowed in this passage, please see detailed Description for LDAC.
干预措施: Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine (Drug)
结局指标
主要结局
Minimal Residual Disease (MRD).
时间窗: Day 22 MRD measurement
Detection of Minimal Residual Disease following one course of chemotherapy where positive MRD was defined as one or more leukemic cell per 1000 mononuclear bone-marrow cells (\>=0.1%).
次要结局
- Proportion of Patients Experienced Toxicity of Cytarabine + Daunomycin + Etoposide (ADE) + GO.(Induction II)
- To Estimate the Overall Event-free Survival (EFS) of AML Patients Who Undergo Risk-adapted and Genotype-directed Therapy(Five Year)
- Proportion of Minimal Residual Disease (MRD)+ Patients Who Become MRD- After One Course of Gemtuzumab Ozogamicin (GO)(Consolidation I)
- Proportion of MRD Reduction After One Course of Cytarabine + Daunomycin + Etoposide (ADE) + GO(Induction II)
- To Assess Whether Inhibition of DNA Synthesis is Greater After High-dose Ara-C (HDAC) Than After Low-dose Ara-C (LDAC) Therapy(Measurements were assessed in Induction I chemotherapy)
- Relationship of Inhibition of DNA Synthesis and Clinical Response(Measurements were assessed in Induction I chemotherapy)