A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Number of Participants With Dose Limiting Toxicities
研究概览
简要总结
This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.
详细描述
In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks
In the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.
A sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Relapsed AML
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy > 3 months
- •≥ 18 years old
- •Previously untreated for current AML relapse
- •Adequate organ function
- •Written informed consent
排除标准
- •Pregnant or breast-feeding women
- •Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days
- •Currently receiving another investigational drug
- •Currently receiving other anti-cancer agents
- •Uncontrolled infection
- •HIV positive
- •Received previous therapy with either Mylotarg or 5-azacitidine
研究组 & 干预措施
Phase 1 Dose Level 1
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2
干预措施: 5-Azacitidine (Drug)
Phase 1 Dose Level 1
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza 2 days then GO at 3 mg/m^2
干预措施: Gemtuzumab ozogamicin (Drug)
Phase 1 Dose Level 2
5-Azacitidine, Gemtuzumab ozogamicin
75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2
干预措施: 5-Azacitidine (Drug)
Phase 1 Dose Level 2
5-Azacitidine, Gemtuzumab ozogamicin
75mg/m^2 5-Aza for 4 days then GO at 6 mg/m^2
干预措施: Gemtuzumab ozogamicin (Drug)
Phase I Dose Level 3
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
干预措施: 5-Azacitidine (Drug)
Phase I Dose Level 3
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
干预措施: Gemtuzumab ozogamicin (Drug)
Phase 2 Dose Level 1
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
干预措施: 5-Azacitidine (Drug)
Phase 2 Dose Level 1
5-Azacitidine, Gemtuzumab ozogamicin
75 mg/m^2 5-Aza for 6 days then GO at 6 mg/m^2
干预措施: Gemtuzumab ozogamicin (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities
时间窗: up to 28 days
MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.
次要结局
- Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine(Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years)
研究者
Edward Ball
Professor of medicine
University of California, San Diego