ALinC 17: Protocol for Patients With Newly Diagnosed High Risk Acute Lymphoblastic Leukemia (ALL) - Evaluation of the Augmented BFM Regimen: A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 20
- 主要终点
- Augmented Berlin Frankfurt Muenster (BFM) therapy is superior to ALinC 14/15 therapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective for acute lymphoblastic leukemia.
PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy in treating children who have newly diagnosed acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
- Determine whether augmented BFM therapy is superior to ALinc 14/15 therapy in patients with newly diagnosed high-risk acute lymphoblastic leukemia.
- Determine whether minimal residual disease after induction therapy is predictive of an inferior prognosis in this patient population.
- Determine the correlation between event-free survival, minimal residual disease, and early response in this patient population treated with this multiple drug regimen.
OUTLINE: Patients are stratified by CNS or testicular disease (yes vs no).
- Induction therapy (weeks 1-5): Patients receive oral prednisone 3 times daily on days 1-29; vincristine IV on days 1, 8, 15, and 22; daunorubicin IV on days 8, 15, 22; and asparaginase intramuscularly (IM) on days 2, 5, 8, 12, 15, and 19. Patients also receive methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS 2 or 3 disease also receive methotrexate IT on days 15 and 22.
Patients with M1 bone marrow proceed to consolidation therapy. Patients achieving M2 bone marrow on day 29 receive oral prednisone 3 times daily on days 29-42; vincristine IV and daunorubicin IV over 15 minutes on days 29 and 36; and asparaginase IM on days 29, 32, 36, and 39. If bone marrow is M3 on day 29 or M2 on day 43, then patient is off study.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of B-cell precursor acute lymphoblastic leukemia
- •Registered on POG-9900 Classification Study
- •Registered within 7 days of documenting complete response after induction on day 29 or, if 2 more weeks of induction are required, no later than day 49
- •Classified as high risk:
- •No simultaneous trisomy 4 and 10
- •No TEL-AML1 gene
- •Meets criteria for 1 of the following:
- •Any age with WBC > 100,000/mm^3
- •CNS and bone marrow evaluations required for those patients with WBC > 100,000/mm^3 who are within 24 months of initial diagnosis
- •Age over 12 (boys) or 16 (girls)
- •If younger, WBC must be 1 of the following:
- •Greater than 80,000/mm^3 (for boys age 8 or girls age 12)
- •Greater than 60,000/mm^3 (for boys age 9 or girls age 13)
- •Greater than 40,000/mm^3 (for boys age 10 or girls age 14)
- •Greater than 20,000/mm^3 (for boys age 11 or girls age 15)
- •At least one of the following:
- •CNS 3 disease (CSF WBC at least 5/microliter with blasts present)
- •Testicular leukemia
- •MLL gene rearrangements
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Augmented Berlin Frankfurt Muenster (BFM) therapy is superior to ALinC 14/15 therapy
To determine for patients at high risk for treatment failure if the augmented Berlin Frankfurt Muenster (BFM) therapy is superior to ALinC 14/15 therapy, on the basis of historical controls.
次要结局
未报告次要终点