Gentuzumab Ozogamicin Berfore Allogeneic Stem Cell Transplantation in Patients With Relapsed CD33+ Acute Myeloid Leukemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Documentation of the extramedullary toxicity of the standard therapy
研究概览
简要总结
Study Design:
prospective phase II trial with 30 patients in 1 site
Treatment Scheme:
Option 1: Patient < 60 years of age with relapse after chemotherapy or > 12 months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -6 to -3 TBI 2x2 Gy day -3 to -2 (total dose 8 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to day 40 PBSC day 0
Option 2: Patient > 60 years of age or younger patients < 12 Months after hematopoetic stem cell transplantation Mylotarg 6 mg/ m² day -21 Mylotarg 3 mg/ m² day -14 Fludarabin 30 mg/ m² day -3 to -1 TBI 1x2 Gy day 0 (total dose 2 Gy) Tacrolimus (level adapted) from day -3 on Mycophenolat 2 x 1000 mg p.o. from day 0 to 40 PBSC day 0
详细描述
Scientific/Medical Rationale (Objective):
Primary:
documentation of the extramedullary toxicity of the standard therapy
Secondary:
Induction of a persistent remission by the combination of Mylotarg and dose reduced conditioning followed by allogenic hematopoetic stem cell transplantation in patients with relapsed acute myelotic leukemia
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- patients with acute myelotic leukemia and expression of CD33 on > 5% of blasts in bone marrow
- •relapse after chemotherapy
- •relapse after autologous or allogenic hematopoetic stem cell transplantation
- •pts. in 2nd remission after chemotherapy and ineligible for a conventional allogeneic transplantation
- •age: 18-70 years
- •informed consent of the patient
- •ASAT/ ALAT < 3fold of upper standard
- •Bilirubin < 2fold of upper standard
- •ejection fraction > 40% in echocardiography
- •potential donor in accordance with the following priorities:
- •1st HLA-identical related donor (HLA *A, *B, *C and *DR)
- •2nd HLA-identical non-related donor with the maximum of 1 allelmismatch (DNA typing A, B, C, DRB1, DQB1)
排除标准
- 未提供
结局指标
主要结局
Documentation of the extramedullary toxicity of the standard therapy
次要结局
- Induction of a persistent remission by the combination of Mylotarg and dose reduced conditioning followed by allogenic hematopoetic stem cell transplantation in patients with relapsed acute myelotic leukemia