Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9,350
- 试验地点
- 486
- 主要终点
- DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
研究概览
简要总结
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
l. To determine if a maintenance regimen containing weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of patients with standard-risk B-precursor acute lymphoblastic leukemia (ALL). (Complete effective January 13, 2017) II. To determine whether a reduced-pulses maintenance regimen with vincristine (vincristine sulfate)/dexamethasone pulses delivered every 12 weeks can be used without adversely impacting DFS as compared to pulses given every 4 weeks in the AR subset of patients with standard risk B-precursor ALL.
III. To confirm that patients in the low-risk (LR) subset of standard risk B-precursor ALL, based on clinical and cytogenetic features and minimal residual disease (MRD) criteria, can attain a 5 year DFS of at least 95% with either a P9904 based regimen that includes 6 courses of intermediate dose (1 g/m^2 over 24 hours) methotrexate without alkylating agents or anthracyclines (Arm LR-M), or an outpatient based regimen identical to that of AR patients with reduced vincristine/dexamethasone pulses at 12 week intervals during maintenance (Arm LR-C).
IV. To provide standardized treatment and enhanced supportive care to children with standard-risk (SR) Down syndrome B-ALL in order to improve outcomes and facilitate further study of this biologically and clinically unique patient subgroup.
V. To improve understanding of the biology of localized B-lineage lymphoblastic lymphoma (B-LLy) and Down syndrome (DS) B-LLy by obtaining biologic data, including fluorescence in situ hybridization (FISH) for recurrent cytogenetic lesions on paraffin specimen, and banking tissue for future research.
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 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
- •Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932
- •B-ALL patients must have an initial white blood cell count < 50,000/uL
- •Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible
- •Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted
- •All patients and/or their parents or legal guardians must sign a written informed consent
- •All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met
排除标准
- •With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932
- •Patients receiving prior steroid therapy may be eligible for AALL0932
- •Patients with central nervous system 3 (CNS3) leukemia
- •CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy
- •B-ALL patients with testicular leukemia are not eligible for AALL0932
- •For B-LLy patients the following additional exclusion criteria apply:
- •T-lymphoblastic lymphoma
- •Morphologically unclassifiable lymphoma
- •Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
- •CNS3-positive disease or testicular involvement
- •M2 (5% - 25% blasts) or M3 (> 25% blasts) marrow
- •Female patients who are pregnant are ineligible
- •Lactating females are not eligible unless they have agreed not to breastfeed their infants
- •Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- •Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
研究组 & 干预措施
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Dexamethasone (Drug)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Mercaptopurine (Drug)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Methotrexate (Drug)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Questionnaire Administration (Other)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Laboratory Biomarker Analysis (Other)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Quality-of-Life Assessment (Other)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Questionnaire Administration (Other)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Laboratory Biomarker Analysis (Other)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Cyclophosphamide (Drug)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Questionnaire Administration (Other)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Questionnaire Administration (Other)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Pegaspargase (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Methotrexate (Drug)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Methotrexate (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Dexamethasone (Drug)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Mercaptopurine (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Methotrexate (Drug)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Laboratory Biomarker Analysis (Other)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Quality-of-Life Assessment (Other)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Questionnaire Administration (Other)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Laboratory Biomarker Analysis (Other)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Quality-of-Life Assessment (Other)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Questionnaire Administration (Other)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Quality-of-Life Assessment (Other)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Questionnaire Administration (Other)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Quality-of-Life Assessment (Other)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Questionnaire Administration (Other)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Cyclophosphamide (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Cytarabine (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Doxorubicin Hydrochloride (Drug)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Methotrexate (Drug)
Arm A (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Vincristine Sulfate (Drug)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Dexamethasone (Drug)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Methotrexate (Drug)
Arm B (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on days 1, 29, and 57; dexamethasone PO BID on days 1-5, 29-33, and 57-61; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Vincristine Sulfate (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Cytarabine (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Dexamethasone (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Doxorubicin Hydrochloride (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Leucovorin Calcium (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Mercaptopurine (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Pegaspargase (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Thioguanine (Drug)
Arm B-LLy (4-week cycle maintenance)
See Detailed Description.
干预措施: Vincristine Sulfate (Drug)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Dexamethasone (Drug)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Mercaptopurine (Drug)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Methotrexate (Drug)
Arm C (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Vincristine Sulfate (Drug)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Dexamethasone (Drug)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Mercaptopurine (Drug)
Arm D (risk-adapted chemotherapy)
Patients receive vincristine sulfate IV on day 1; dexamethasone PO BID on days 1-5; higher-dose methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; mercaptopurine PO on days 1-84; and IT methotrexate on day 1.
干预措施: Vincristine Sulfate (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Cyclophosphamide (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Cytarabine (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Dexamethasone (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Doxorubicin Hydrochloride (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Mercaptopurine (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Thioguanine (Drug)
Arm LR-C (risk-adapted chemotherapy)
Patients receive consolidation, interim maintenance I, delayed intensification, interim maintenance II, and maintenance therapy. See detailed description.
干预措施: Vincristine Sulfate (Drug)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Dexamethasone (Drug)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Leucovorin Calcium (Drug)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Mercaptopurine (Drug)
Arm LR-M (risk-adapted chemotherapy)
Patients receive consolidation and maintenance therapy. See detailed description.
干预措施: Vincristine Sulfate (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Leucovorin Calcium (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Mercaptopurine (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Methotrexate (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Pegaspargase (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Thioguanine (Drug)
Arm SR DS (12-week cycle maintenance)
See Detailed Description
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
时间窗: 5.1 years
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated.
Overall Survival (OS) for B-LLy Patients
时间窗: 5 years
OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated.
Sample Collection of Central Path Review Slides in B-LLy Patients
时间窗: Up to 1 month
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported.
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
时间窗: 5.1 years
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
Event Free Survival (EFS) for B-LLy Patients
时间窗: 5 years
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated.
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
时间窗: 5.7 years
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
时间窗: 5.7 years
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
次要结局
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional(1.7 years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical(1 Year)
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional(2 Months)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional(2.5 years)
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical(2 Months)
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: School(3.2 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right(1 Year)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional(1 year)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical(1.7 years)
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical(3.2 years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: School(1 Year)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: School(1.7 Years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School(2.4 years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning(1.7 Years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning(2.4 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional(1.7 years)
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional(3.2 years)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical(2.4 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional(2.4 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical(1.7 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: School(1.7 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): School(2.4 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning(2.4 Years)
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: School(2 Months)
- Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning(2 Months)
- Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning(1 Year)
- Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning(3.2 Years)
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional(3.2 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical(2.4 Years)
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning(3.2 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right(4.2 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left(2.4 Years)
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical(3.2 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left(2 Months)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left(2.4 Years)
- Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: School(3.2 Years)
- Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning(1.7 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right(2 Months)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left(1 Year)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left(4.2 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right(2.4 Years)
- Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right(2.4 Years)