EUCTR2009-015176-10-FR进行中（未招募）不适用
CLOFARABINE/ARA-C TREATMENT COMBINED WITH REDUCED-INTENSITY CONDITIONING ALLOGENEIC STEM CELL TRANSPLANTATION FOR ACUTEMYELOID LEUKEMIA IN PRIMARY TREATMENT FAILURE - SET-RIC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leu-kemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease) OR AML with cytogenetic or hematological relapse within 6 months from documentation of first complete remission.
- •- Age: 18-65 years.
- •- Availability of an HLA identical family donor OR unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
- •- Signed informed consent
- •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
- •- Documented chloroma
- •- Documented leukemic infiltration of CNS/cerebrospinal fluid
- •- Karnofsky performance score below < 60%
- •- Acute or chronic heart failure
- •- Severe renal failure (createnine clearance < 50 ml/min)
- •- Severe liver failure (transaminases or bilirubine > 4x the upper limit of normal)
- •- HIV infection, chronic viral hepatitis
- •- Severe neurological or psychiatric disorders
- •- Any circumstances that provide the use of the drugs used within the protocol
- •- Prior allogeneic or autologous stem cell transplantation
- •- > 3 courses of prior chemotherapy
- •- Denied informed consent
- •- Pregnancy
研究者
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