EUCTR2008-007043-14-GB进行中（未招募）不适用
A Pilot Study of Clofarabine Pre-Conditioning Prior to Full or Reduced Intensity Allogeneic Transplantation in the Treatment of High Risk Acute Myeloid Leukaemia and Myelodysplasia - Clofarabine pre-conditioning with allogeneic transplant for AM
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2010年8月27日最近更新:
相关药物
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
- •1.Cytologically and immunophenotypically (or immunohistochemically) confirmed diagnosis of high risk AML or MDS as defined by the following criteria:
- •Primary refractory disease as defined by failure to achieve complete remission after one course of intensive chemotherapy appropriate for the therapy of AML
- •Early relapse following induction or consolidation chemotherapy (within 12 months)
- •Second or subsequent relapse
- •AML secondary to documented myelodysplasia, myeloproliferative disorder or prior chemotherapy/radiation
- •Progressive myelodysplasia with excess blasts.
- •Poor risk cytogenetics
- •2.Minimum age of 18 years
- •3.Eligible for allogeneic stem cell transplant by local institutional guidelines
- •4.Suitable matched-related/sibling or volunteer unrelated donor available, as determined by local institutional guidelines
- •5.Negative pregnancy test for females of child-bearing potential within 7 days prior to the start of study treatment
- •6.If sexually active, male and female subjects must agree that they will use an effective method of birth control throughout the active study period
- •7.Written informed consent
- •8.Capable of and willing to comply with scheduled visits, treatment plan and required laboratory tests
- •9.Adequate renal and hepatic function as indicated by defined laboratory criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study
- •2.Previous Allogeneic Bone Marrow or Peripheral Blood Stem Cell Transplant.
- •3.Pregnant or lactating women. All female subjects of child-bearing potential must have a negative pregnancy test within 7 days prior to the start of treatment.
- •4.Any current active, invasive malignancy excluding AML or MDS
研究者
相似试验
已完成
1 期
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)Acute Myeloid LeukaemiaMyelodysplasiaNCT01422603University Hospital Southampton NHS Foundation Trust9
已完成
不适用
Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.Acute lymphoblastic leukemia10024324NL-OMON41476HOVO285
进行中（未招募）
不适用
Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBLMedDRA version: 18.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864EUCTR2008-005798-36-BEHOVON Foundation340
进行中（未招募）
1 期
Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults.Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBLMedDRA version: 17.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10043028Term: T-lymphoblastic lymphoma (Kiel Classification)System Organ Class: 100000004864EUCTR2008-005798-36-NLHOVON Foundation376
已完成
1 期
CLOfarabine (Clolar®) Used with DaunoXome® in acute myeloid leukaemiaAcute myeloid leukaemiaMyeloid leukaemiaCancerISRCTN29644734niversity of Birmingham (UK)18