Allogeneic Stem Cell Transplantation Following by Targeted Immune Therapy) (Gemtuzumab Ozogamicin) in Average Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome (AML/MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- to evaluate incidence of graft failure
研究概览
简要总结
Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.
详细描述
Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.
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
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Status:
- •AML 1st CR with a matched family donor
- •AML 1st CR with unrelated donor
- •AML 2nd CR or CRP
- •MDS and < or = 5% bone marrow myeloblasts at diagnosis
- •Disease Immunophenotype:
- •Disease must express a minimum of > or = 10% CD33 positivity for patients with AML
- •Organ Function:
- •Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function
排除标准
- •Patients with active CNS AML disease at time of preparative regimen
- •Secondary MDS
- •Poor cytogenetics
- •Female patients who are pregnant
- •Karnofsky <70% or Lansky <50% if 10 years or less
- •Age >25 years
- •Seropositive for HIV
研究组 & 干预措施
Gemtuzumab Ozogamicin
Consolidation therapy with GO will be administered between days 60 and 180 post transplantation when the ANC is >1000/mm3 and platelet count is >40,000/mm3 untransfused x 3 days after AlloSCT and again at minimum 8 weeks later.
干预措施: Gemtuzumab Ozogamicin (Drug)
结局指标
主要结局
to evaluate incidence of graft failure
时间窗: Day +42
If three or more of the first ten patients experience primary or secondary graft failure, we will discontinue the study.
to evaluate survival rates
时间窗: 1 year
Event-free survival and overall survival after RI AlloSCT and targeted immunotherapy in patients with average risk AML/MDS.
to determine toxicity
时间窗: 1 year
to monitor for serious adverse events related to protocol investigational therapy
次要结局
- Minor histocompatibility antigen(1 year)
- Chimerism(1 year)
- Graft-versus-host disease(1 Year)
研究者
Mitchell Cairo
Principal Investigator
New York Medical College