Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
This goal of this clinical research study is to learn if the combination of methotrexate, pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients) can help to control ALL that has not responded to previous treatment or has come back after a response or chronic myeloid leukemia (CML).
详细描述
The Study Drugs:
Methotrexate is designed to disrupt cells from making and repairing DNA (the genetic material of cells) and "copying" themselves.
Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Pegylated-L-asparaginase is designed to get rid of an important building block of proteins in leukemia cells.
Dexamethasone is a steroid that causes the leukemia cells to breakdown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory; without viable stem cell transplant option. Patients with previously treated Philadelphia chromosome positive ALL will be also eligible;
- •Chronic myeloid leukemia in blast phase
- •Zubrod performance status </= 3;
- •Adequate liver function (bilirubin </= 3.0mg/dl, unless considered due to tumor),and renal function (creatinine </= 3.0 mg/dl unless considered due to tumor;
- •Age >/= to 1 year
- •Understand and voluntarily sign an informed consent form.
- •For pediatric patients (age >/= 1 year to </= 18 years), Lansky performance status >/=50
- •For pediatric patients (age >/= 1 year to </= 18 years), second or greater relapse
排除标准
- •Pregnant patients
- •Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
研究组 & 干预措施
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
干预措施: PEG-l-asparaginase (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
干预措施: Dexamethasone (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
干预措施: Methotrexate (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
干预措施: Vincristine (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: 6 cycles (cycle = 28 days)
Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above and platelet count of 100 x 10\^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
次要结局
未报告次要终点