The Use of Modified BFM +/- Compound 506U78 (Nelarabine) (NSC# 686673, IND #52611) in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0
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. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia
详细描述
PRIMARY OBJECTIVES:
I. Determine the feasibility of the addition of nelarabine to modified multiagent Berlin-Frankfurt-Muenster-86 chemotherapy in patients with newly diagnosed T-cell acute lymphoblastic leukemia.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics and intracellular pharmacology of nelarabine in these patients.
OUTLINE: This is a pilot, multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
- •High-risk disease, defined as meeting at least 1 of the following criteria:
- •WBC at least 50,000/mm^3
- •Age 10 years or over
- •Patients with WBC at least 25,000/mm^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
- •Concurrent registration to POG 9900 within the past 8 days required
- •Performance status - Karnofsky 50-100% (over 10 years of age)
- •Performance status - Lansky 50-100% (10 years of age and under)
- •See Disease Characteristics
- •Bilirubin no greater than 1.5 mg/dL
- •SGPT less than 5 times normal
- •Creatinine normal
- •Creatinine clearance or glomerular filtration rate at least 60 mL/min
- •No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No prior biologic therapy
- •No more than 72 hours since prior intrathecal cytarabine
- •No other prior chemotherapy
- •Prior steroids allowed
- •No chronic steroid treatment for another disease
- •Prior emergency radiotherapy to mediastinum for severe respiratory distress allowed
排除标准
- 未提供
研究组 & 干预措施
Regimen D
See detailed description.
干预措施: cytarabine (Drug)
Regimen A
See detailed description.
干预措施: cytarabine (Drug)
Regimen A
See detailed description.
干预措施: prednisone (Drug)
Regimen A
See detailed description.
干预措施: vincristine sulfate (Drug)
Regimen A
See detailed description.
干预措施: daunorubicin hydrochloride (Drug)
Regimen A
See detailed description.
干预措施: asparaginase (Drug)
Regimen A
See detailed description.
干预措施: methotrexate (Drug)
Regimen A
See detailed description.
干预措施: cyclophosphamide (Drug)
Regimen A
See detailed description.
干预措施: mercaptopurine (Drug)
Regimen A
See detailed description.
干预措施: leucovorin calcium (Drug)
Regimen A
See detailed description.
干预措施: dexamethasone (Drug)
Regimen A
See detailed description.
干预措施: doxorubicin hydrochloride (Drug)
Regimen A
See detailed description.
干预措施: thioguanine (Drug)
Regimen A
See detailed description.
干预措施: radiation therapy (Radiation)
Regimen A
See detailed description.
干预措施: pharmacological study (Other)
Regimen A
See detailed description.
干预措施: laboratory biomarker analysis (Other)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: prednisone (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: vincristine sulfate (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: daunorubicin hydrochloride (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: asparaginase (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: methotrexate (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: cyclophosphamide (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: cytarabine (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: mercaptopurine (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: leucovorin calcium (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: dexamethasone (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: doxorubicin hydrochloride (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: thioguanine (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: radiation therapy (Radiation)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: nelarabine (Drug)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: pharmacological study (Other)
Regimen B
Induction (weeks 1-9): Patients receive treatment as in induction of regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166.
Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.
干预措施: laboratory biomarker analysis (Other)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: prednisone (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: vincristine sulfate (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: daunorubicin hydrochloride (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: asparaginase (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: methotrexate (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: cyclophosphamide (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: cytarabine (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: mercaptopurine (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: leucovorin calcium (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: dexamethasone (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: doxorubicin hydrochloride (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: thioguanine (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: radiation therapy (Radiation)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: nelarabine (Drug)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: pharmacological study (Other)
Regimen C
Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33.
If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues.
Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A.
Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A.
Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B.
Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.
干预措施: laboratory biomarker analysis (Other)
Regimen D
See detailed description.
干预措施: prednisone (Drug)
Regimen D
See detailed description.
干预措施: vincristine sulfate (Drug)
Regimen D
See detailed description.
干预措施: daunorubicin hydrochloride (Drug)
Regimen D
See detailed description.
干预措施: asparaginase (Drug)
Regimen D
See detailed description.
干预措施: methotrexate (Drug)
Regimen D
See detailed description.
干预措施: cyclophosphamide (Drug)
Regimen D
See detailed description.
干预措施: nelarabine (Drug)
Regimen D
See detailed description.
干预措施: mercaptopurine (Drug)
Regimen D
See detailed description.
干预措施: leucovorin calcium (Drug)
Regimen D
See detailed description.
干预措施: dexamethasone (Drug)
Regimen D
See detailed description.
干预措施: thioguanine (Drug)
Regimen D
See detailed description.
干预措施: pegaspargase (Drug)
Regimen D
See detailed description.
干预措施: radiation therapy (Radiation)
Regimen D
See detailed description.
干预措施: pharmacological study (Other)
Regimen D
See detailed description.
干预措施: laboratory biomarker analysis (Other)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: prednisone (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: vincristine sulfate (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: daunorubicin hydrochloride (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: asparaginase (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: methotrexate (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: cyclophosphamide (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: cytarabine (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: mercaptopurine (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: leucovorin calcium (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: dexamethasone (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: thioguanine (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: nelarabine (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: pegaspargase (Drug)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: radiation therapy (Radiation)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: pharmacological study (Other)
Regimen E
Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.
干预措施: laboratory biomarker analysis (Other)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: prednisone (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: vincristine sulfate (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: daunorubicin hydrochloride (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: asparaginase (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: methotrexate (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: cyclophosphamide (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: cytarabine (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: mercaptopurine (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: leucovorin calcium (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: dexamethasone (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: thioguanine (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: nelarabine (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: pegaspargase (Drug)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: radiation therapy (Radiation)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: pharmacological study (Other)
Regimen F
Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0
时间窗: Up to 6 years
次要结局
未报告次要终点