NCT00961142终止2 期
Multicenter Phase II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts After a Reduced Intensity Conditioning Regimen for Adult Patients With Acute Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 16
- 主要终点
- Evaluation of treatment related mortality after haploidentical HCT
研究概览
简要总结
Feasibility and toxicity of haploidentical allogeneic HCT after a reduced intensity conditioning regimen with CD3/CD19 depleted grafts. This study enrolls patients with acute leukemia in complete remission with an indication for allogeneic HCT but without a suitable HLA-identical donor
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
- •Patients with either ALL or AML in CR with an indication for allogeneic HCT according to the following criteria:
- •AML: high risk patients with one or more of the following risk factors:
- •FLT-3 mutation
- •Complex cytogenetics
- •abn(3q), -5/5q-, -7/7q-, abn(12p), abn(17p)
- •Late CR > induction I
- •Patients in 2.CR
- •Secondary AML
- •Relapse after a preceding allogeneic HCT from an HLA-identical donor
- •ALL: high risk patients with one or more of the following risk factors:
- •Pro-B-ALL
- •Initial WBC >30.000/µL
- •CR after day 46 after Induction II
- •Complex cytogenetics, t(9,22), t(4,11)
- •Early or mature T-ALL
- •Initially refractory patients with late CR
- •Rising MRD level
- •Patients in
- •Relapse after a preceding allogeneic HCT from an HLA-identical donor
- •No HLA-identical donor (not more than 1 antigen mismatch (9/10-Match) or more than 2 allelic mismatches by high-resolution typing). Critical cases should be discussed with the PI.
- •Age <=65, >=18 years
- •Karnofsky Index >60%
排除标准
- •Patients with >5% blasts in BM at the time of transplantation
- •Less than 3 months after preceding HCT
- •CNS involvement with disease
- •History of neurologic impairment such as: seizures, severe peripheral neuropathy, signs of leukoencephalopathy, CNS infection, multiple intrathecal chemotherapies, CNS irradiation. In case of heavy pretreatment with irradiation or intrathecal chemotherapy pretransplant CNS MRI and neurological consultation are mandatory
- •Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month.
- •Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher 2x upper limit of normal.
- •Chronic active viral hepatitis
- •Ejection fraction <40 % on echocardiography
- •Patients with > grade II hypertension by CTC criteria
- •Creatinine clearance <50 ml/min
- •Respiratory failure necessitating supplemental oxygen or DLCO <30%
- •Allergy against murine antibodies
- •HIV-Infection
- •Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry)
- •Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
- •Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- •Patients unwilling or unable to comply with the protocol
- •Unable to give informed consent
- •Enrollment in an other trial interfering with the endpoints of this study
结局指标
主要结局
Evaluation of treatment related mortality after haploidentical HCT
时间窗: 1 year after HCT
Cumulative Incidence of treatment related mortality
次要结局
- Evaluate Engraftment(One year after HCT)
- Evaluate Toxicity(One year after HCT)
- Evaluate Disease Free Survival(1, 2 and 5 years after inclusion)
- overall survival(1, 2 and 5 years after inclusion)
研究者
Prof. Dr. med. Wolfgang Bethge
Prof. Dr.
University Hospital Tuebingen
研究点 (16)
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