Azacitidine Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for AML and MDS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to Toxicity
研究概览
简要总结
Primary Objective:
-To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS.
Secondary Objective:
-To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.
详细描述
Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. Women who are able to have children must have a negative blood pregnancy test.
If you are found to be eligible to take part in this study, you will be given chemotherapy, before the transplant of donor cells. There are 2 major goals to giving this chemotherapy. One goal is to directly kill leukemic cells. The other goal is to block your ability to reject the donor cells that will be given to your for the transplantation.
All participants will receive a combination of 3 chemotherapy drugs--gemtuzumab, fludarabine, and melphalan. In order to receive gemtuzumab, your bone marrow leukemia cells have to be positive for a marker called "CD33," which is present in the majority of myeloid leukemias. If your cells are negative for that marker, the chemotherapy you receive will not include gemtuzumab. Anti-thymocyte globulin (ATG) will be given to patients receiving stem cells from an unrelated donor, or from a relative that is not fully matched with you.
All chemotherapy drugs are given by vein through a silicone catheter. Gemtuzumab is given 12 days before the transplant (may be given as an outpatient infusion). Fludarabine is given once a day for 4 days (5-2 days before the transplant), and melphalan is given as a single dose 2 days before the transplant. If you are receiving ATG, this drug will be given in 3 doses, given 3-1days before the transplant. The transplant day is usually referred to as "Day 0."
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in.
- •Induction Failure, relapsed disease or second or greater remission.
- •Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission.
- •Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or
- •HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch)
- •Age 18 to 75 years and
- •Left ventricular ejection fraction >40% and
- •FEV1, FVC and DLCO >40% and
- •Serum creatinine <1.6 mg/dL and
- •Serum bilirubin < 1.6 mg/dL and
- •SGPT < 3 X upper limit of normal and
- •All patients and donors or guardian should be able to understand and sign informed consent.
- •Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test.
排除标准
- •HIV positive
- •AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.)
- •Active uncontrolled infection
- •Pregnancy or breastfeeding
研究组 & 干预措施
Azacitidine
Azacitidine after Allogeneic Transplantation
干预措施: Azacitidine (Drug)
结局指标
主要结局
Time to Toxicity
时间窗: Baseline with 30 day cycles (up to 4 cycles), approximately 116 days
次要结局
未报告次要终点