NCT00017589已完成2 期
Phase II Study of Genasense (Bcl-2 Antisense) Combined With Mylotarg (Gemtuzumab Ozogamicin) in Elderly Patients With Relapsed Acute Myeloid Leukemia
Genta Incorporated2 个研究点 分布在 1 个国家开始时间: 2000年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Oblimersen may help gemtuzumab ozogamicin kill more cancer cells by making cancer cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining oblimersen and gemtuzumab ozogamicin in treating older patients who have relapsed acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine the complete response rate of elderly patients with relapsed CD33-positive acute myeloid leukemia treated with oblimersen and gemtuzumab ozogamicin.
- Determine the overall response rate and duration of response of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oblimersen IV continuously on days 1-7 and 15-22 and gemtuzumab ozogamicin IV over 2 hours on days 4 and 18.
Patients are followed monthly for 6 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 CD33+ acute myeloid leukemia (AML)
- •In first relapse from chemotherapy
- •Complete response lasting at least 3 months before relapse
- •No CNS leukemia
- •No secondary leukemia or history of antecedent hematologic disorder prior to initial onset of AML (e.g., myelodysplasia)
- •PATIENT CHARACTERISTICS:
- •60 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC less than 30,000/mm^3
- •No bleeding or coagulation disorder except disease-related disseminated intravascular coagulation
- •Bilirubin no greater than 1.5 mg/dL
- •PT and PTT no greater than 1.5 times upper limit of normal OR
- •INR no greater than 1.3
- •No history of chronic hepatitis or cirrhosis
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No uncontrolled congestive heart failure
- •No New York Heart Association class III or IV heart disease
- •No severe pulmonary disease
- •HIV negative
- •No other concurrent medical disease that would preclude study entry
- •No known hypersensitivity to phosphorothioate-containing oligonucleotides, gemtuzumab ozogamicin or any of its components, E. coli protein, or any product produced in E. coli
- •No other concurrent malignancy
- •No known human anti-human antibodies
- •No uncontrolled seizure disorder
- •No active uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior allogeneic or autologous stem cell transplantation
- •No prior therapy with an anti-CD33 antibody (e.g., gemtuzumab ozogamicin or M195)
- •Chemotherapy:
- •See Disease Characteristics
- •At least 2 weeks since prior cancer chemotherapy except intrathecal chemotherapy or hydroxyurea
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 2 weeks since prior systemic radiotherapy
- •At least 2 weeks since prior major surgery
- •No prior organ allograft
- •At least 3 weeks since prior antileukemic therapy and recovered
- •No other concurrent investigational therapy
- •No concurrent immunosuppressive therapy
排除标准
- 未提供
研究者
研究点 (2)
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