EUCTR2011-002192-41-DE进行中（未招募）1 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 - Treo-Rapa Mismatch
niversity Hospital Tübingen0 个研究点目标入组 60 人开始时间: 2011年12月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 lower or equal 75, higher or equal 18 years
- •Patients Age below 50 if a HCT-CI score > 2 [acc. to Sorror et al., 2005]
- •Karnofsky Index >60%
- •Patients with:
- •Acute myeloid leukaemia in CR (<5% blasts)
- •Acute lymphoblastic leukaemia in CR (< 5% blasts)
- •Myelodysplastic syndrome with up to 20% blasts
- •High grade Non-Hodgkin Lymphoma in CR
- •Low grad Non-Hodgkin Lymphoma in CR or PR
- •Chronic myeloid leukaemia in chronic phase or CR of blast crisis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
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
研究者
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