EUCTR2008-006972-31-IT进行中（未招募）不适用
Clinical phase II trial to evaluate the safety and efficacy of clofarabine and treosulfan conditioning prior to peripheral blood stem cells transplantation in paediatric and adult patients with advanced haematological malignancies - ND
OSPEDALE S. RAFFAELE0 个研究点开始时间: 2008年11月12日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 with haematological malignancies such as
- •- acute myeloid leukaemia -AML- beyond CR1
- •- acute lymphoblast leukaemia -ALL- beyond CR1
- •- chronic myeloid leukaemia -CML- beyond chronic phase (CP1)
- •- myelodysplastic syndrome -MDS- such as RCMD, RAEB1 and RAEB2
- •Availability of a
- •-HLA-identical sibling donor (MRD) or
- •-HLA-identical unrelated donor (MUD) with HLA-identity defined by the following markers: A and B at antigenic level; DRB1 at allelic level. However every patient and donor will be typed at allelic level at HLA-A, B, C, DRB1, DQB1. If no class I and class II completely identical donor (i.e. 10 out of 10) can be identified, no more than two allele disparity between patient and donor is acceptable. The target graft size (unmanipulated) will be: 4 - 10 x 106 CD34+ cells/kg BW recipient
- •Have adequate renal and hepatic functions as indicated by the following laboratory values:
- •Pediatric Population: Calculated creatinine clearance ≥ 90 ml/min/1.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 adolescent boys.
- •Adult Population: Serum creatinine 1.0 mg/dL; if serum creatinine 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be 60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black.
- •Serum bilirubin ≤1.5 × upper limit of normal (ULN)
- •Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 × ULN
- •Alkaline phosphatase  2.5 × ULN
- •Karnofsky Index > 80 %
- •Age > 1 and < 70 years
- •Adequate contraception in female patients of child-bearing potential
- •Written informed consent
- •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.Secondary malignancies
- •2.Previous allogeneic transplantation
- •3.Hematopoietic cell transplantation-specific comorbidity index (HCT-CI > 4 (Sorror et al Appendix M)
- •1.Secondary malignancies
- •2.Previous allogeneic transplantation
- •3.Hematopoietic cell transplantation-specific comorbidity index (HCT-CI > 4 (Sorror et al Appendix M)
- •4.HIV- positivity or active hepatitis infection
- •5.Pleural effusion or ascites > 1.0 L
- •6.Pregnancy or lactation
- •7.Known hypersensitivity to treosulfan and/or clofarabine
- •8.Participation in another experimental drug trial within 4 weeks before day -6
- •9.Non-cooperative behaviour or non-compliance
- •10.Psychiatric diseases or conditions that might impair the ability to give informed consent
研究者
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