EUCTR2014-003124-44-DE进行中（未招募）1 期
Evaluation of the impact of remission induction chemotherapy prior to allogeneic stem cell transplantation in relapsed and poor-response patients with AML - ETAL3-ASAP
DKMS gemeinnützige GmbH0 个研究点目标入组 308 人开始时间: 2014年7月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 308
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
- •- Signed written informed consent.
- •- Male and female patients of 18 to 75 years of age.
- •- Diagnosis of AML according to WHO criteria.
- •- Patient is fit for aggressive induction chemotherapy and transplantation by assessment of an experienced hematologist.
- •- No known history of chronic pulmonary disease and absence of dyspnea. Otherwise, documented diffusion lung capacity for carbon monoxide (DLCO) =40% (adjusted for hemoglobin, if available) and FEV1/FVC = 50%.
- •- HLA-identical sibling.
- •- HLA-compatible unrelated donor (=9/10 antigens matched for HLA-A, -B, -C, -DRB1, and –DQB1) with completed confirmatory typing
- •- Two unrelated donors with >90% probability of 9/10 match for HLA-A, -B, -C, -DRB1, and –DRQB1, according to OptiMatch® list.
- •- Relapse patients: First AML relapse, defined as =5% bone marrow blasts and / or extramedullary AML manifestation.
- •- Poor-responders: with =5% bone marrow blasts after the first cycle of induction therapy, and one of the following subtypes/risk groups of AML:
- •-AML that evolves from previously documented myelodysplastic syndrome (MDS), or after a Myeloproliferative Neoplasia (MPN) or
- •Diagnosis of therapy-related myeloid neoplasm (t-MN)or
- •-Non favourable risk AML according to ELN-criteria
- •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 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •- Acute promyelocytic leukemia (APL).
- •WBC count of =50 GPt/L at study inclusion.
- •- For poor-responder patients the first cycle of induction therapy contained HDAC, defined as cytarabine at single-doses of >1g/ m2.
- •- Patient has received more than 440 mg/m2 daunorubicin equivalents
- •- Severe organ dysfunction, defined as any of the following:
- •Left ventricular ejection fraction <50%.
- •Patients who receive supplementary continuous oxygen.
- •Serum bilirubin >1.5 x ULN (if not considered Gilbert-Syndrome), or ASAT/ALAT >5 x ULN.
- •Estimated GFR < 50 ml/min.
- •- Treatment with any investigational drug within 10 days before study entry.
- •- Uncontrolled infection at the time of enrollment.
- •- History of allogeneic transplantation.
- •- Manifestation of AML in the central nervous system.
- •- Pregnant or breast-feeding women.
- •- Men unable or unwilling to use adequate contraception methods from start of study treatment to minimum of six months after the last dose of chemotherapy.
- •-Women with childbearing potential except those who fulfill the following criteria: Post-menopausal or post-operative or continuous and correct application of a contraception method with a Pearl Index < 1 % or sexual abstinence or vasectomy of the sexual partner.
研究者
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