NCT00354276Unknown2 期
A Phase II Study of Cloretazine® (VNP40101M) for Elderly Patients With De Novo Poor Risk Acute Myelogenous Leukemia
Vion Pharmaceuticals6 个研究点 分布在 3 个国家目标入组 85 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Complete response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the complete response rate in older patients with poor-risk, de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy.
Secondary
- Determine the probability of overall survival, leukemia-free survival, and progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed de novo acute myeloid leukemia (AML)
- •No acute promyelocytic leukemia [t(15;17)]
- •No favorable cytogenetics, including t(15;17), t(8;21), or inv 16
- •No secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS] or myeloproliferative disease), or history of prior chemotherapy or radiation for a disease other than AML
- •Must have ≥ 1 of the following poor-risk features:
- •Any of the following unfavorable cytogenetics:
- •Del (5q)/-5q
- •-7/del(7q)
- •Abnormal 3q, 9q, 11q, 20q, 21q, or 17p
- •Trisomy 8
- •Complex karyotypes (≥ 3 unrelated abnormalities)
- •At least 70 years of age
- •ECOG performance status (PS) of 2
- •Cardiac dysfunction* that would limit the use of anthracycline therapy, as defined by any of the following:
- •Ejection fraction ≤ 50%
- •History of significant coronary artery disease, defined as ≥ 1 vessel stenosis requiring medical treatment, stent placement, or surgical bypass graft
- •History of congestive heart failure or myocardial infarction
- •Significant arrhythmia, including any of the following:
- •Atrial flutter (excluding atrial fibrillation)
- •Sick sinus syndrome
- •Ventricular arrhythmia
- •Heart valve disease
- •Mitral valve prolapse allowed
- •Other heart disease, at the discretion of the principal investigator
- •Pulmonary dysfunction not related to AML, defined by 1 of the following:
- •DLCO and/or FEV_1 < 80% and ≥ 50% normal range
- •Dyspnea on slight activity or at rest
- •Requires oxygen
- •Hepatic dysfunction related to chronic hepatitis or liver cirrhosis
- •Other organ dysfunction or comorbidity that precludes standard cytotoxic induction treatment (e.g., "3+7"), at the discretion of the principal investigator NOTE: *Patients with a history of heart disease as defined above must be on appropriate medication and have their disease under control
- •No known CNS disease
- •PATIENT CHARACTERISTICS:
- •ECOG PS 0-2
- •AST and ALT ≤ 5 times upper limit of normal
- •Bilirubin ≤ 2.0 mg/dL
- •Creatinine ≤ 2.0 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- •No active, uncontrolled infection
- •Patients with an infection who are under active treatment with antibiotics and whose infections are controlled are eligible
- •Chronic hepatitis allowed
- •No clinical evidence of ongoing second malignancy unrelated to AML or MDS
- •No evidence of left bundle branch block on screening ECG
- •No obligate use of cardiac pacemaker or atrial fibrillation
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 24 hours since prior metronidazole
- •No prior low-dose, single-agent, cytotoxic chemotherapy (e.g., cytarabine, decitabine, or azacitidine)
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Complete response rate
次要结局
- Leukemia-free survival
研究者
研究点 (6)
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