EUCTR2012-005535-90-BE进行中（未招募）1 期
Sequential administration of 5-azacytidine (AZA) and donor lymphocyte infusion (DLI) for patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) in relapse after allogeneic stem cell transplantation.
CHU Mont-Godinne0 个研究点目标入组 50 人开始时间: 2013年6月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
入选标准
- •-Age = 18 years.
- •-Be able to understand and sign informed consent.
- •-Fertile patients must use a reliable contraception method.
- •Disease status at transplantation :
- •-Acute myelogenous leukemia (AML) in first or subsequent complete remission (< 5% marrow blasts).
- •-Myelodysplastic syndrome (MDS) with less than 10% marrow blasts at the time of transplantation.
- •Transplantation :
- •-Allogeneic transplantation using a sibling or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of one allele or one antigen or 1 antigen + 1 allele or 1 antigen + 1 DQB1 antigen or 2 alleles mismatches.
- •-Standard or reduced-intensity conditioning.
- •-Second transplantation is allowed.
- •-Donor is willing to donate lymphocytes.
- •Clinical situation:
- •-Cytologic relapse after allo-stem cell transplantation defined as the recurrence of more than 5% blasts on bone marrow aspiration (AML) or evidence of MDS
- •-Immunophenotypic relapse defined as the recurrence of an abnormal phenotype on flow cytometry in bone marrow aspirate.
- •-Cytogenetic or molecular relapse defined as the persistence or recurrence of a cytogenetic abnormality or molecular marker in bone marrow aspiration or peripheral blood. WT1 expression is not considered as reliable marker for relapse in this protocol but FLT3-ITD, NPM1, CEBPA, or translocation-specific markers (such as MLL-PTD, AML-ETO, CBFB-MYH11) are.
- •Immunosuppressive therapy should have been stopped before inclusion.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-More than 30% marrow blasts at the time of inclusion.
- •-Extramedullary relapse including central nervous involvement.
- •-ECOG Performance status > 2.
- •-Active acute grade II-IV GvHD at the time of inclusion.
- •-Active chronic GvHD requiring systemic therapy at the time of inclusion.
- •-Uncontrolled infection.
- •-HIV positive.
- •-Acute or chronic heart failure (NYHA class III or IV) or symptomatic ischemic heart disease or
- •ejection fraction < 35% or uncontrolled arrhythmia.
- •-Severe liver failure (total bilirubin > 3 mg/dL, SGPT > 4 X upper normal limit).
- •-Severe pulmonary failure (corrected DLCo < 35%).
- •-Terminal renal failure requiring dialysis.
- •-Severe neurological or psychiatric disorders.
- •-Concurrent investigational drug.
- •-Other treatment for relapse, except for hydroxyurea but it should be stopped before inclusion in the study.
- •-Female who is pregnant or breastfeeding.
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