Intensive Induction Therapy for Children With Acute Lymphoblastic Leukemia (ALL) Who Experience a Bone Marrow Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Feasibility assessed by excessive early deaths, induction failures, and early relapses
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of using an intensified sequential induction regimen to treat children with acute lymphoblastic leukemia (ALL), who experience an isolated, or combined bone marrow relapse.
II. To determine the potential of this regimen to serve, as a backbone, for the future testing of novel therapeutic agents.
SECONDARY OBJECTIVES:
I. To estimate the remission re-induction rates and four-month event-free survival (EFS) for children, stratified by the duration of first remission.
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
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
- •Shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
- •Cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- •Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
- •Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
- •Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
- •They received SCT less than 12 months prior to study entry
- •They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
- •They have active fungal infection at time of study entry
- •They have had invasive filamentous fungal infection at any time post-SCT
- •Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
- •Patients with prior isolated extramedullary relapse are ineligible
研究组 & 干预措施
Arm I
See detailed description.
干预措施: cytarabine (Drug)
Arm I
See detailed description.
干预措施: methotrexate (Drug)
Arm I
See detailed description.
干预措施: vincristine sulfate (Drug)
Arm I
See detailed description.
干预措施: prednisone (Drug)
Arm I
See detailed description.
干预措施: pegaspargase (Drug)
Arm I
See detailed description.
干预措施: doxorubicin hydrochloride (Drug)
Arm I
See detailed description.
干预措施: imatinib mesylate (Drug)
Arm I
See detailed description.
干预措施: cyclophosphamide (Drug)
Arm I
See detailed description.
干预措施: etoposide (Drug)
Arm I
See detailed description.
干预措施: filgrastim (Biological)
Arm I
See detailed description.
干预措施: leucovorin calcium (Drug)
Arm I
See detailed description.
干预措施: asparaginase (Drug)
Arm II
See detailed description.
干预措施: cytarabine (Drug)
Arm II
See detailed description.
干预措施: methotrexate (Drug)
Arm II
See detailed description.
干预措施: vincristine sulfate (Drug)
Arm II
See detailed description.
干预措施: prednisone (Drug)
Arm II
See detailed description.
干预措施: pegaspargase (Drug)
Arm II
See detailed description.
干预措施: doxorubicin hydrochloride (Drug)
Arm II
See detailed description.
干预措施: imatinib mesylate (Drug)
Arm II
See detailed description.
干预措施: cyclophosphamide (Drug)
Arm II
See detailed description.
干预措施: etoposide (Drug)
Arm II
See detailed description.
干预措施: filgrastim (Biological)
Arm II
See detailed description.
干预措施: leucovorin calcium (Drug)
Arm II
See detailed description.
干预措施: asparaginase (Drug)
Arm II
See detailed description.
干预措施: therapeutic hydrocortisone (Drug)
结局指标
主要结局
Feasibility assessed by excessive early deaths, induction failures, and early relapses
时间窗: Up to 4 months
Toxicity assessed using CTC version 2.0
时间窗: Up to 4 months
Will be tabulated in detail.
次要结局
- Overall remission reinduction (CR2) rate(Up to 4 months)
- EFS(4 months)
- MRD(Up to 4 months)
- Feasibility of combining intensive re-induction therapy with imatinib mesylate(Up to 4 months)
- Percentage of patients who were able to complete the triple re-induction therapy with imatinib mesylate(Up to 4 months)