EUCTR2010-024297-19-BE进行中（未招募）1 期
Allogeneic hematopoietic cell transplantation from HLA-matched donors after reduced-intensity conditioning: a phase II randomized study comparing 2 GVHD prophylaxis regimen - Comparison of Two GVHD Prophylaxis Regimens
CHU de Liege0 个研究点目标入组 200 人开始时间: 2011年1月18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
- 200
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
- •Hematological malignancies confirmed histologically and not rapidly progressing:
- •- AML in CR (defined as = 5% marrow blasts and absence of blasts in the peripheral blood);
- •- MDS with = 5% marrow blasts and absence of blasts in the peripheral blood;
- •- CML in CP;
- •- MPS not in blast crisis and not with extensive marrow fibrosis,
- •- ALL in CR;
- •- Multiple myeloma not rapidly progressing;
- •- Non-Hodgkin’s lymphoma (aggressive NHL should have chemosensitive disease);
- •- Hodgkin’s disease with chemosensitive disease.
- •Clinical situations:
- •Theoretical indication for a standard allo-transplant, but not feasible because:
- •- Age > 50 yrs;
- •- Unacceptable end organ performance;
- •- At the physician’s decision;
- •- Patient’s refusal.
- •Indication for a standard auto-transplant:
- •-perform mini-allotransplantation 2-6 months after standard autotransplant.
- •Other inclusion criteria
- •-Male or female; fertile patients must use a reliable contraception method;
- •-Age =75 yrs (children of any age are allowed in the protocol);
- •-Informed consent given by patient or his/her guardian if of minor age.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any condition not fulfilling inclusion criteria;
- •HIV positive;
- •Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT;
- •Life expectancy severely limited by disease other than malignancy;
- •Administration of cytotoxic agent(s) for cytoreduction” within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
- •CNS involvement with disease refractory to intrathecal chemotherapy.
- •Terminal organ failure, except for renal failure (dialysis acceptable)
- •-a.Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension;
- •-b.Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
- •-c.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;
- •Uncontrolled infection;
- •Karnofsky Performance Score <70%;
- •Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
- •Patient is a female who is pregnant or breastfeeding;
- •Any condition precluding the use of sirolimus or MMF.
研究者
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