NCT00089050已完成2 期
A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Efficacy in terms of complete remission rate
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.
- Determine the toxicity and pharmacokinetics of this regimen in these patients.
Secondary
- Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.
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:
- •Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate
- •More than 20% blasts by morphologic criteria
- •Relapsed disease ≥ 3 months after prior complete remission
- •Blasts CD33-positive by flow cytometry
- •No primary hematologic disorder that preceded initial presentation with AML
- •No documented secondary AML related to prior chemotherapy or toxin exposure
- •No acute promyelocytic leukemia (FAB M3)
- •Not a candidate for transplant therapy
- •No active CNS leukemia
- •PATIENT CHARACTERISTICS:
- •60 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≤ 30,000/mm^3 (hydroxyurea allowed)
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 mg/dL
- •HIV negative
- •No uncontrolled infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not planning hematopoietic stem cell transplantation immediately after study therapy
- •Chemotherapy
- •See Disease Characteristics
- •See Hematopoietic
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 1 month since prior investigational agents
- •No other concurrent anticancer therapy
- •No administration of any of the following for 24 hours after cyclosporine administration:
- •Diltiazem
- •Verapamil
- •Erythromycin
- •Clarithromycin
- •Metoclopramide
- •Phenytoin
- •Phenobarbital
- •Aminoglycosides
- •Amphotericin B
- •Vancomycin
- •Cimetidine
- •Ranitidine
- •Trimethoprim/sulfamethoxazole
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Efficacy in terms of complete remission rate
Toxicity
Pharmacokinetics
次要结局
- Correlate clinical response to laboratory studies of drug susceptibility
研究者
研究点 (1)
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