Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,377
- 试验地点
- 236
- 主要终点
- Event-free Survival (EFS) for SR-Average ALL Patients
研究概览
简要总结
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. 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.
详细描述
PRIMARY OBJECTIVES:
I. To determine whether the substitution of three intensified phases of post-Induction treatment for standard phases will improve the event free survival (EFS) of children with SR-average acute lymphoblastic leukemia (ALL).
II. Determine whether the substitution of intensified Consolidation for standard Consolidation will improve the EFS of children with SR-average ALL.
III. To determine whether the addition of four doses of percutaneous endoscopic gastrostomy (PEG) asparaginase, given once every three weeks during Consolidation and Interim Maintenance phases, will improve the EFS for children with SR-low ALL.
SECONDARY OBJECTIVES:
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 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331
- •Initial white blood cells (WBC) < 50,000/ul
- •Newly diagnosed B-precursor acute lymphoblastic leukemia
- •Standard-risk (SR) disease meeting 1 of the following criteria:
- •SR-average by age and WBC
- •No unfavorable features
- •Rapid early responder (RER) by day 15
- •CNS 1 or 2
- •Minimal residual disease (MRD) negative on day 29
- •Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
- •SR-low by age and WBC
- •No unfavorable features
- •RER by day 15
- •MRD negative on day 29
- •Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
- •Unfavorable features meeting ≥ 1 of the following criteria:
- •MLL rearrangements and RER
- •Steroid pretreatment
- •Slow early responder by morphology or MRD
- •Patients with Down syndrome are allowed
- •Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232
- •Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the central nervous system [CNS] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
- •Patients receiving prior steroid therapy may be eligible for AALL0331 study
- •Patients with a contraindication to additional asparaginase therapy, following Induction, are not eligible for the Standard Risk-Low study, and should be removed from protocol therapy at the end of Induction
- •Patients who are assigned to the standard risk-average group following Induction and who meet the HRQOL
- •Age at diagnosis >= 2 years (note that this is a more restrictive age range than for the therapeutic component of the study)
- •At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist
- •Diagnosis at one of the institutions participating in this limited institution correlative study
- •A parent or legal guardian must sign a written informed consent/parental permission for all patients
- •All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
排除标准
- 未提供
研究组 & 干预措施
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Cytarabine (Drug)
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Dexamethasone (Drug)
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Leucovorin Calcium (Drug)
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Methotrexate (Drug)
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Pegaspargase (Drug)
Group 0 Induction Therapy
All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) < 0.1% OR MRD >= 0.1% and < 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD >= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
干预措施: Vincristine Sulfate (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Cyclophosphamide (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Cytarabine (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Dexamethasone (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Doxorubicin Hydrochloride (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Leucovorin Calcium (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Mercaptopurine (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Methotrexate (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Pegaspargase (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Thioguanine (Drug)
Group 1-SR-low ALL, Arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
干预措施: Vincristine Sulfate (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Mercaptopurine (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 1-SR-low ALL, arm II (combination chemotherapy)
Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Vincristine Sulfate (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cyclophosphamide (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cytarabine (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Doxorubicin Hydrochloride (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Mercaptopurine (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 2-SR-avg ALL, arm I (combination chemotherapy)
Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Thioguanine (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cyclophosphamide (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cytarabine (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Doxorubicin Hydrochloride (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Thioguanine (Drug)
Group 2-SR-avg ALL, arm II (combination chemotherapy)
Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Vincristine Sulfate (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cyclophosphamide (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cytarabine (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Vincristine Sulfate (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Doxorubicin Hydrochloride (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Mercaptopurine (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 2-SR-avg ALL, arm III (combination chemotherapy)
Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Thioguanine (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cyclophosphamide (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cytarabine (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Doxorubicin Hydrochloride (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Mercaptopurine (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Thioguanine (Drug)
Group 2-SR-avg ALL, arm IV (combination chemotherapy)
Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Vincristine Sulfate (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cyclophosphamide (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Dexamethasone (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Cytarabine (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Doxorubicin Hydrochloride (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Leucovorin Calcium (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Mercaptopurine (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Methotrexate (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Pegaspargase (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Thioguanine (Drug)
Group 3-SR-high ALL, combination chemotherapy
Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
Event-free Survival (EFS) for SR-Average ALL Patients
时间窗: 6 years
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Event-free Survival (EFS) for SR-Low Patients
时间窗: 6 years
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
次要结局
- Health-related Quality of Life Relative to Physical, Social and Emotional Impairment(At 1, 6 and 12 months after diagnosis and, 3 months post-therapy)
- Event-Free Survival Probability According to MRD Status End Induction (Day 29)(MRD at Day 29 of therapy)
- Overall Survival Probability (OS) According to Induction Day 29 MRD Status(Overall Survival Probability of 6 years)
- Early Marrow Status (EMS) by MRD Status End Induction (Day 29)(Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.)
- Optimal Time Point for Advance Health Related Quality of Life Intervention(At 1 month after diagnosis and 3 months post-therapy.)
- Event-free Survival (EFS) for SR-High Patients.(6 years)
- Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)(6 years)