A Randomized Trial of the I-BFM-SG for the Management of Childhood Non-B Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A donor stem cell transplant may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop the growth of cancer cells and stop the patient's immune system from rejecting the donor's stem cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying different risk-adjusted combination chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- To test in a randomized way the type and intensity of reintensification therapy for pediatric patients with acute lymphoblastic leukemia in each risk group: standard-risk (SR), intermediate-risk (IR), and high-risk (HR) group.
- To compare two shorter elements of reintensification (protocol III x 2 courses) to one (protocol II x 1 course) in terms of effectiveness when cumulative dose of most drugs are the same in both regimen in patients in the standard-risk group.
- To determine if the increased risk of failure in patients in the intermediate-risk group can be curtailed by a third reintensification element (protocol III x 3 courses vs protocol II x 1 course).
- To determine if the three reintensification elements (protocol III x 3 courses) achieve the same or better results in high-risk group patients, as compared with current applied HR approach in Berlin-Frankfurt-Münster Group (BFM) or Italian Association of Pediatric Hematology and Oncology (AIEOP).
OUTLINE: This is a partially randomized, multicenter study. Patients are stratified according to risk group (standard risk [SR] vs intermediate risk [IR] vs high risk [HR]). Patients are randomized in reinduction part of the treatment.
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Induction therapy:
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Protocol I' (SR B-cell precursor [BCP] ALL ): Patients receive methotrexate intrathecally (IT) on days 1, 12, and 33 (and possibly on days 18 and 27); prednisone or prednisolone orally or IV on days 1-28 followed by a taper; vincristine sulfate IV on days 1, 8, 15, 22, and 29; daunorubicin hydrochloride IV over 1 hour on days 8 and 15; and asparaginase IV over 1 hour on days 12, 15, 18, 21, 24, 27, 30, and 33. Patients then receive cyclophosphamide IV over 1 hour on days 36 and 64; oral mercaptopurine once daily on days 36-63; cytarabine IV continuously on days 38-41, 45-48, 52-55, and 59-62; and methotrexate IT on days 45 and 59.
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Protocol I (SR T-cell ALL, IR, or HR): Patients receive therapy as in Protocol I' except that they also receive daunorubicin hydrochloride on days 22 and 29.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 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
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: methotrexate (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: asparaginase (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: cyclophosphamide (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: cytarabine (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: dexamethasone (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: doxorubicin hydrochloride (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: thioguanine (Drug)
Arm I
During reinduction, patients receive 1 course of protocol II.
干预措施: vincristine sulfate (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: asparaginase (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: cyclophosphamide (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: cytarabine (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: dexamethasone (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: doxorubicin hydrochloride (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: mercaptopurine (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: methotrexate (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: thioguanine (Drug)
Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
干预措施: vincristine sulfate (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: asparaginase (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: cyclophosphamide (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: cytarabine (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: daunorubicin hydrochloride (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: dexamethasone (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: doxorubicin hydrochloride (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: etoposide (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: ifosfamide (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: leucovorin calcium (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: mercaptopurine (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: methotrexate (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: prednisone (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: thioguanine (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: vincristine sulfate (Drug)
Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
干预措施: vindesine (Drug)
结局指标
主要结局
Disease-free survival
Event-free survival
Overall survival
次要结局
未报告次要终点