EUCTR2010-023436-16-NL进行中（未招募）不适用
The feasibility and efficacy of subcutaneous and intravenous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA–identical sibling donors: a randomized phase II study. - HOVON 107 MOBILIZATIO
HOVON Foundation0 个研究点开始时间: 2011年4月15日最近更新:
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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
- •HLA identical sibling donor
- •Age 18-60 years inclusive
- •Hematologic parameters within normal limits
- •Capable of undergoing leucapheresis: adequate venous access. Must be willing to undergo insertion of a central catheter should leucapheresis via peripheral vein be inadequate
- •Willing and able to have bone marrow aspiration if there is mobilization failure
- •Negative pregnancy test at study entry for women of childbearing potential
- •Willing and able to use adequate contraception during the mobilization and collection period
- •Written informed consent from donor
- •Age 18-65 years inclusive
- •Patients with a cytopathologically confirmed diagnosis of:
- •- De novo Acute Myeloid Leukemia according to WHO classification in first complete
- •remission (excluding acute promyelocytic leukemia) OR
- •- Myelodysplasia refractory anemia with excess of blasts (RAEB) with IPSS = 1.5 in first
- •complete remission OR
- •- Therapy related AML/RAEB in first complete remission OR
- •- Biphenotypic leukemia in first complete remission OR
- •- De novo B or T Lineage Acute Lymphatic Leukemia in first complete remission.
- •WHO performance score 0,1 or 2
- •Patients should have an HLA- identical sibling donor
- •Life expectancy >3 months
- •Negative pregnancy test at study entry for women of childbearing potential
- •Willing and able to use adequate contraception
- •Written informed consent from patient
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Monozygotic twin
- •Unstable hypertension requiring more than 1 medication.
- •Positive serology for hepatitis C or HbsAg
- •Treatment with other investigational drugs
- •HIV positivity
- •Pregnant or breastfeeding female subject
- •Patients who are treated with a kinase-inhibitor
- •Cardiac dysfunction
- •Severe pulmonary dysfunction (CTCAE grade 3-4)
- •Severe neurological or psychiatric disease
- •Significant hepatic dysfunction
- •Significant renal dysfunction
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.)
- •Patient known to be HIV-positive
- •Pregnant or breast-feeding female patients.
- •Presence of other active malignancy or a history of active malignancy during the past 5 years, other than non melanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits
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