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临床试验/NCT00381680
NCT00381680已完成3 期

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Children's Oncology Group173 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2007年3月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
275
试验地点
173
主要终点
Event Free Survival. EFS
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell 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) and giving the drugs in different ways and different doses may kill more cancer cells..

详细描述

PRIMARY OBJECTIVES:

I. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia.

SECONDARY OBJECTIVES:

I. To determine levels of minimal residual disease (MRD) present at the end of the first & third blocks of Induction and determine if higher MRD levels at these times identify patients at higher risk of relapse who might be candidates for alternative therapies in future trials.

II. To determine whether common polymorphisms in candidate genes are associated with the frequency of vincristine adverse effects (peripheral neuropathy, syndrome of inappropriate antidiuretic hormone secretion [SIADH], or constipation) and with anti-leukemic response (level of end-Induction MRD).

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 29 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of acute lymphoblastic leukemia (ALL)
  • •Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)
  • •Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc translocation are not eligible (considered Burkitt's or mature B-cell leukemia)
  • •Intermediate-risk relapsed disease, meeting 1 of the following criteria:
  • •Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow after previous remission from ALL)
  • •Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36 months after initial diagnosis
  • •Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after initial diagnosis
  • •The following subtypes are not allowed:
  • •T-lineage ALL
  • •Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of c-myc translocation)
  • •Philadelphia-chromosome positive disease
  • •No Down syndrome (trisomy 21)
  • •Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by radionuclide angiogram
  • •Bilirubin < 3.0 mg/dL
  • •Not pregnant
  • •Fertile patients must use effective contraception
  • •No history of peripheral neuropathy >= grade 3 within the past month
  • •No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine within the past month
  • •At least 5 days since prior intrathecal chemotherapy
  • •No prior hematopoietic stem cell or marrow transplantation
  • •No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)
  • •No concurrent stem cell transplant
  • •No concurrent alternative therapy
  • •No concurrent itraconazole in patients receiving vincristine
  • •No concurrent intensity-modulated radiotherapy

排除标准

  • 未提供

研究组 & 干预措施

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: cyclophosphamide (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: vincristine sulfate (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: prednisone (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: doxorubicin hydrochloride (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: pegaspargase (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: cytarabine (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: methotrexate (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: dexamethasone (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: etoposide (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: leucovorin calcium (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: filgrastim (Biological)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: asparaginase (Drug)

Regimen A: Standard vincristine dosing

Active Comparator

See detailed description.

干预措施: mercaptopurine (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: vincristine sulfate (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: prednisone (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: doxorubicin hydrochloride (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: pegaspargase (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: cytarabine (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: methotrexate (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: dexamethasone (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: etoposide (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: cyclophosphamide (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: leucovorin calcium (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: filgrastim (Biological)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: asparaginase (Drug)

Arm B: Randomized High Dose Vincristine regimen

Experimental

See detailed description. Closed to accrual as of 09/2010).

干预措施: mercaptopurine (Drug)

结局指标

主要结局

Event Free Survival. EFS

时间窗: 3 years after enrollment

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT).

次要结局

  • Gene Expression Profile(Up to 36 months)
  • Frequency and Severity of Adverse Effects(Up to 107 weeks)
  • Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1(End of Block 1 (35 days) of Induction therapy)
  • Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3(End of Block 3 (105 days) of Induction therapy)
  • Event Free Survival (EFS)(3 years)
  • Adjusted Event Free Survival(3 years)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (173)

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