NCT00682305已完成2 期
Allogeneic Stem Cell Transplantation With Treosulfan, VP-16 and Cyclophosphamide for Patients With Acute Lymphoblastic Leukemia (ALL) Not Eligible for TBI-containing Conditioning Regimen: A Phase II-study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT
研究概览
简要总结
The present study is a multicenter, prospective phase II-study investigating the combination of treosulfan, etoposide, and cyclophosphamide as conditioning regimen for patients with acute lymphoblastic leukemia who are not eligible for a TBI-containing regimen.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute lymphoblastic leukemia in first or subsequent complete remission
- •Indication for allogeneic stem cell transplantation according to the actual protocol of the German Acute Lymphoblastic Leukemia Study Group
- •Patient's age: 18-65 years
- •HLA-identical or compatible related or unrelated donor (HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed)
- •Not eligible for total-body irradiation due to one of the following reasons:
- •prior radiation of the spine > 30 Gy
- •prior radiation of the mediastinum > 30 Gy
- •severe pulmonary infection during induction chemotherapy
- •DLCO > 50%
- •Patient's wishing to avoid total-body irradiation as conditioning regimen
- •Patient's written informed consent
- •Women and men capable of reproduction must agree to use highly effective methods of contraception until six months after treatment termination. For men: vasectomy, sexual abstinence, or partner is using hormonal IUD, implants, injectables, oral hormonal contraceptives or is surgically sterilized. For women: hormonal IUD, implants, injectables, sexual abstinence, surgical sterilization, vasectomised partner
排除标准
- •No complete remission at time of registration
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •total bilirubin, SGPT or SGOT > 3 times upper the normal level
- •Left ventricular ejection fraction < 30%
- •Creatinine clearance < 30 ml/min
- •DLCO < 35% and/ or receiving supplementary continuous oxygen
- •Positive serology HIV
- •Pregnant or lactating women
- •Severe florid infection
- •Experienced hypersensitivity against cyclophosphamid, etoposide, or treosulfan
- •Obstructive renal function
- •Participation in any other clinical drug trial
- •Serious psychiatric or psychological disorders
- •Progressive invasive fungal infection at time of registration
结局指标
主要结局
Evaluation of engraftment at day +28 and non-relapse mortality at day +100 and at 1 year after SCT
时间窗: 1 year after SCT
次要结局
- *Incidence of aGvHD on day +100/ cGvHD at 1 and 2 yrs after SCT/ relapse at 2 yrs after SCT *Toxicity *Disease-free survival at 2 yrs after SCT *overall survival at 2 yrs. after SCT(2 years after transplantation)
研究者
研究点 (2)
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