A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 51
- 主要终点
- Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia.
- Determine the event-free survival of patients treated with this regimen.
- Determine the clinical prognostic features associated with outcome in these patients.
- Compare the biologic characteristics of the leukemia cells with outcome in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease).
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Modified Augmented BFM Therapy
干预措施: methylprednisolone (Drug)
Modified Augmented BFM Therapy
干预措施: asparaginase (Drug)
Modified Augmented BFM Therapy
干预措施: cyclophosphamide (Drug)
Modified Augmented BFM Therapy
干预措施: cyclosporine (Drug)
Modified Augmented BFM Therapy
干预措施: cytarabine (Drug)
Modified Augmented BFM Therapy
干预措施: daunorubicin hydrochloride (Drug)
Modified Augmented BFM Therapy
干预措施: dexamethasone (Drug)
Modified Augmented BFM Therapy
干预措施: doxorubicin hydrochloride (Drug)
Modified Augmented BFM Therapy
干预措施: mercaptopurine (Drug)
Modified Augmented BFM Therapy
干预措施: methotrexate (Drug)
Modified Augmented BFM Therapy
干预措施: pegaspargase (Drug)
Modified Augmented BFM Therapy
干预措施: thioguanine (Drug)
Modified Augmented BFM Therapy
干预措施: vincristine sulfate (Drug)
Modified Augmented BFM Therapy
干预措施: allogeneic bone marrow transplantation (Procedure)
Modified Augmented BFM Therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group
次要结局
- Grade 3 or 4 non-hematologic toxicity rates
- Event-free survival