A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Response (CR)
研究概览
简要总结
The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Gemtuzumab ozogamicin is designed to attach to Sialic acid-binding Ig-like lectin 3 (CD33), a certain protein that is often found in leukemia cells, causing them to die.
Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive decitabine through a needle in your vein over 1 and 1/2 hours on Days 1-5 of each cycle. You will also receive gemtuzumab ozogamicin by vein over about 1 hour after you receive decitabine on Day 5 of each 4-6 week cycle.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent form.
- •Age >/= to 16 years at the time of signing the informed consent form.
- •Diagnosis of Acute myeloid leukemia (AML) [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk Intermediate-2 or high by International Prognostic Scoring System (IPSS) or >/= to 10% blasts) MDS will also be eligible. All non-hematological toxicity of previous cancer therapy should have resolved to </= grade 1 (except alopecia or other toxicities not involving major organs).
- •Eastern Cooperative Oncology Group (ECOG) performance status of </= to 3 at study entry.
- •Laboratory test results within these ranges (unless due to leukemia): Serum creatinine </= 2 mg/dL Total bilirubin </= 2 mg/dL aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) </= 2.5 x ULN or </= 5 times Upper limit of normal (ULN) if related to disease
- •Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
排除标准
- •Pregnant or breastfeeding females.
- •Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk.
- •Use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression.
- •Use of hydrea to control proliferative disease will be allowed prior to starting therapy on study and for up to 7 days each during cycle 1-3 (Maximum daily dose of 7gm).
研究组 & 干预措施
Decitabine + Gemtuzumab Ozogamicin
Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days, Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
干预措施: Decitabine (Drug)
Decitabine + Gemtuzumab Ozogamicin
Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days, Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
干预措施: Gemtuzumab Ozogamicin (Drug)
结局指标
主要结局
Number of Participants With Complete Response (CR)
时间窗: Up to 36 weeks
Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.
次要结局
未报告次要终点