NCT00006020已完成2 期
A Phase II Trial of 506U78 (IND 52611) in Patients With Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 107
- 主要终点
- CR
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory acute lymphocytic leukemia.
详细描述
OBJECTIVES:
- Assess the complete remission rate in patients with recurrent or refractory non-T-cell acute lymphocytic leukemia when treated with 506U78.
- Determine the frequency and severity of toxic effects of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every month for 6 months, every 3 months for 1 year, and then every 6 months for 3.5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of acute lymphocytic leukemia (ALL)
- •FAB class L1-L2
- •Non-T-cell ALL (lymphocytic immunophenotype markers CD19+, CD5-, and CD7- in peripheral blood, bone marrow, or in at least 1 extramedullary disease site)
- •Coexpression of myeloid antigens CD13 or CD33 allowed
- •Histologically confirmed extramedullary disease in the absence of bone marrow or blood involvement allowed
- •CD3 and myeloperoxidase marker negative
- •Meeting 1 of the following criteria for recurrent/refractory disease:
- •Refractory to standard induction regimen including at least vincristine and prednisone
- •Recurrence after response after prior induction therapy
- •Recurrence and failure on subsequent treatment
- •No CNS involvement
- •Must be registered on SWOG-S9910 and SWOG-9007
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Zubrod 0-3
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT or SGPT no greater than 3 times ULN
- •Creatinine no greater than 2 times ULN
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No grade 2 or greater neuropathy
- •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
结局指标
主要结局
CR
时间窗: After induction therapy is completed
次要结局
未报告次要终点
研究者
研究点 (107)
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