EUCTR2009-014980-38-BE进行中（未招募）1 期
Co-transplantation of mesenchymal stem cells and HLA-mismatched allogeneic hematopoietic cells after reduced-intensity conditioning: a phase II randomized double-blind study. - NA
CHU de Liège0 个研究点目标入组 120 人开始时间: 2010年1月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1. Hematological malignancies confirmed histologically and not rapidly progressing (see E1.1).
- •2. Theoretical indication for a standard allo-transplant, but not feasible because: Age > 55 yrs. Unacceptable end organ performance. Patient’s refusal.
- •3. Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.
- •4. Male or female; fertile female patients must use a reliable contraception method;
- •5. Age < ou = 75 yrs.
- •6. Informed consent given by patient or his/her guardian if of minor age.
- •7. One or two HLA mismatches as described in the protocol.
- •PBSC donors
- •1. Related to the recipient (sibling, parent or child) or unrelated who hve 1-2 HLA mismatches as either:
- •- One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- •- Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
- •- One antigenic mismatch ? 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
- •- One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1
- •- Patients with one single allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1 can also be included in the protocol.
- •2. Male or female;
- •3. Weight > 15 Kg (because of leukapheresis);
- •4. Fulfills generally accepted criteria for allogeneic PBSC donation;
- •5. Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.
- •1. Related to the recipient (sibling, parent or child) or unrelated;
- •2. Male or female;
- •3. Age > 16 yrs (no age limit if same as HSC donor);
- •4. No HLA matching required;
- •5. Fulfills generally accepted criteria for allogeneic HSC donation;
- •6. Informed consent given by donor or his/her guardian if of minor age.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any condition not fulfilling inclusion criteria;
- •2. HIV positive;
- •3. Terminal organ failure, except for renal failure (dialysis acceptable)
- •- Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension;
- •- Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
- •- Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
- •4- Uncontrolled infection, arrhythmia or hypertension;
- •5- Previous radiation therapy precluding the use of 2 Gy TBI;
- •6- 10/10 HLA-A, -B, -C, DRB1 and DQBI allele-matched donor fit to/willing to donate PBSC.
- •1. Any condition not fulfilling inclusion criteria;
- •2. HIV positive;
- •3. Unable to undergo leukapheresis because of poor vein access or other reasons.
- •1. Any condition not fulfilling inclusion criteria;
- •2. HIV positive;
- •3. Known allergy to lidocaine;
- •4. If donor other than HSC donor: any risk factor for transmissible infectious diseases.
研究者
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