Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of a Novel Combination of Pembrolizumab and Decitabine in Relapsed/Refractory Acute Myeloid Leukemia Participants
研究概览
简要总结
Background:
Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not treated. Treatment for AML that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.
Objective:
To test if pembrolizumab, in combination with decitabine, is a possible treatment for people with relapsed or refractory AML.
Eligibility:
Adults 18 years of age and older with refractory AML or relapsed AML.
Design:
Participants will be first screened for eligibility.
The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles. Participants may be in the study for up to 2 years if they are responding to the treatment.
The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an outpatient.
Participants will get pembrolizumab at the beginning of each cycle through an IV.
Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other cycle.
Participants will give blood samples.
Participants will have bone marrow exams. A needle will be inserted into the hip to extract cells from the bone marrow.
Some participants may give a sample of saliva from the inside of their cheek.
Some participants may give a small skin sample. The top layer of the skin is removed.
Some patients may require leukapheresis before starting treatment. This is a procedure to remove leukemia cells in the blood stream.
详细描述
This is a pilot study to determine the feasibility of a novel combination of Pembrolizumab and Decitabine in relapsed/refractory adult AML patients. While both Pembrolizumab and Decitabine are FDA approved agents, this study will explore giving these drugs in combination for this population of patients.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pembrolizumab and Decitabine for treatment of Acute Myeloid Leukemia
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m^2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
干预措施: Pembrolizumab (Drug)
Pembrolizumab and Decitabine for treatment of Acute Myeloid Leukemia
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Up to eight cycles of pembrolizumab will be given during the initial induction phase. Each cycle is 21 days. Decitabine will be administered at a dose of 20 mg/m^2 by intravenous infusion over approximately 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7) for treatment relapsed/refractory AML.
干预措施: Decitabine (Drug)
结局指标
主要结局
Feasibility of a Novel Combination of Pembrolizumab and Decitabine in Relapsed/Refractory Acute Myeloid Leukemia Participants
时间窗: 24 weeks
The number of patients who could be treated with a novel combination of Pembrolizumab and Decitabine in relapsed/refractory Acute Myeloid Leukemia participants without being removed from the protocol due to treatment related toxicities.
次要结局
- Median Days to First Response From Start of Study to Initial Achievement of First Response (mCR, mCRi, CR, CRi, PR, or SD)(At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24))
- Median Days to Best Response From Start of Study to Initial Achievement of Best Response (by the Order of mCR, mCRi, CR, CRi, PR, or SD)(At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24))
- Median Duration (Days) of Response From Initial Achievement of Response to Loss of Response (mCR, mCRi, CR, CRi, PR, or SD)(At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24))
- Median Duration (Days) of Best Response From Initial Achievement of Best Response to Loss of Best Response (by the Order of mCR, mCRi, CR, CRi, PR, or SD)(At the end of each cycle 2 (week 6), 4 (week 12), 6 (week 18), 8 (up to week 24))
- Overall Survival(from enrollment until date of death, assessed up to 24 weeks)