NCT01582048终止2 期
Multicenter Phase II Study of Peritransplantation Immunosuppression Using ATG, Rituximab, Sirolimus and Mycophenolate Mofetil in Patient Receiving Mismatched Hematopoietic Cell Transplantation After Reduced Intensity Conditioning With Fludarabine and Treosulfan
Prof. Dr. med. Wolfgang Bethge8 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 8
- 主要终点
- Treatment related mortality
研究概览
简要总结
Feasibility and toxicity of peritransplantation immunosuppression with ATG, sirolimus, mycophenolate mofetil and rituximab in patients receiving mismatched allogeneic HCT after a reduced intensity conditioning regimen with fludarabine/treosulfan
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for mismatched allogeneic HCT
- •Unrelated donor with maximal 2 antigen or allelic mismatches in HLA-I or HLA-II
- •Age >=75, >=18 years
- •Patients Age <=50 if a HCT-CI score > 2 [acc. to Sorror et al., 2005]
- •Karnofsky Index >60%
- •Patients with:
- •Acute myeloid leukemia in CR (<5% blasts)
- •Acute lymphoblastic leukemia in CR (< 5% blasts)
- •Myelodysplastic syndrome with up to 20% blasts
- •Osteomyelofibrosis
- •Chronic lymphocytic leukemia
- •High grade Non-Hodgkin Lymphoma in CR or PR
- •Low grad Non-Hodgkin Lymphoma in CR or PR
- •M. Hodgkin in CR or PR
- •Chronic myeloid leukaemia in chronic phase or CR of blast crisis
排除标准
- •Patients with >5% blasts in BM at the time of transplantation
- •Progressive or chemorefractory disease
- •Less than 3 months after preceding HCT
- •CNS involvement with disease
- •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
- •Proteinuria >800 mg/24 h
- •Respiratory failure necessitating supplemental oxygen or DLCO <30%
- •Allergy against murine antibodies
- •Known allergy/intolerance against sirolimus or one of it's excipients
- •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
Treatment related mortality
时间窗: 24 months after HCT
次要结局
- Engraftment on day 100(on day 100)
- Disease response(24 months after HCT)
- Toxicity according CTC of protocol on day 100(on day 100)
- Incidence of infections(2 years after HCT)
- Immune reconstitution of CD3, CD3/CD4/CD8, CD56, CD19 cells(24 months after HCT)
- Overall survival(24 months after HCT)
- Incidence of graft versus host disease(24 months after HCT)
- Disease free survival(24 months after HCT)
研究者
Prof. Dr. med. Wolfgang Bethge
Associate Professor Hematology/Oncology
University Hospital Tuebingen
研究点 (8)
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