A Phase I/II Study of Cloretazine in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia or Richter's Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
- Determine the toxic effects of this drug in these patients. (phase I)
- Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
- Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following hematologic malignancies:
- •Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
- •CLL in transformation allowed
- •Richter syndrome
- •Other refractory lymphoproliferative diseases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Creatinine ≤ 2.0 mg/dL
- •Renal dysfunction due to organ infiltration by disease allowed
- •AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
- •Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled infection
- •No symptomatic coronary artery disease
- •No arrhythmia not controlled by medication
- •No uncontrolled, symptomatic congestive heart failure
- •No myocardial infarction within the past 3 months
- •No other uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
- •No other concurrent standard or investigational treatment for this cancer
- •No other concurrent cytotoxic investigational drugs
- •No concurrent disulfiram
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
Toxicity
Efficacy
次要结局
未报告次要终点