A Phase I Study of SJG-136 in Patients With Advanced Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
研究概览
简要总结
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
详细描述
OBJECTIVES:
I. Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome (MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic leukemia (CLL).
II. Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of 1 of the following hematologic malignancies:
- •Acute myeloid leukemia
- •Acute lymphoblastic leukemia
- •Myelodysplastic syndromes
- •Chronic myelogenous leukemia in blastic phase
- •Chronic lymphocytic leukemia
- •Relapsed or refractory disease
- •No immediately available, potentially curable options (e.g., stem cell transplantation) available
- •Bilirubin normal (unless elevated due to Gilbert's syndrome)
- •HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would limit study compliance
- •Recovered from prior therapy
- •ECOG performance status =< 2
- •SGOT and SGPT =< 2.5 times upper limit of normal (ULN)
- •Creatinine normal OR creatinine clearance >= 60 mL/min
- •Primary resistance (i.e., failed to achieve a complete remission [CR] to a standard induction regimen) or relapsed after achievement of a CR.
- •Must have documented failure to last cytotoxic regimen prior to study entry.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •No known CNS disease
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
- •More than 7 days since radiotherapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other anti-leukemia agents except hydroxyurea =< 5 grams/day =< 14 days prior to and during first course of treatment to control blood counts
研究组 & 干预措施
Arm I
Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
干预措施: SJG-136 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
时间窗: 21 days
次要结局
未报告次要终点