NCT01462578已完成2 期
Treatment of Patients With MDS or AML With an Impending Hematological Relapse With Azacitidine (Vidaza)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 11
- 主要终点
- Number of patients with hematological relapse 6 months after start of treatment with azacitidin
研究概览
简要总结
Assessment of efficacy of azacitidine to prevent a relapse
详细描述
Analysis of the effectiveness of azacitidine 6 months after start of therapy to prevent a hematological relapse in MDS or AML patients with significant residuals or an increase of minimal residual disease (MRD) which is defined as:
- decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
- increase in the AML-specific molecular markers in the quantitative PCR for t(6,9), NPM1+ AML >1% (ratio to reference gene) after conventional chemotherapy or allogeneic HSCT or
- persistence of the (above) MRD level >1% after conventional chemotherapy or allogeneic HSCT
- tolerance of azacitidine
- quality of the response of the MRD (major vs. minor) and the relapse-free survival and overall survival 12, 24 and 30 months after starting treatment with azacitidine
- modulation of CD34+, NK- and T-cells of MDS and AML patients by azacitidine
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •Age ≥18 years
- •patients with MDS or AML after conventional chemotherapy or allogeneic HSCT and positive molecular marker such as t(6,9), NPM1 pos. or CD34+ or CD117+ in the case of an allogeneic HSCT
- •MDS or AML without haematological relapse (blasts <5% in the bone marrow), and
- •decrease of CD34 donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ or CD117+ MDS or AML or
- •increase in the AML-specific molecular marker in the quantitative PCR for t(6,9), NPM1+ AML >1% after conventional chemotherapy or allogeneic HSCT or
- •persistence of the (above) MRD levels >1% (relative to the reference gene) after conventional chemotherapy or allogeneic HSCT
- •leukocytes > 3 Gpt/l and platelets >75 Gpt/l (transfusion independent)
排除标准
- •Known history of hypersensitivity to any of the drugs used or their constituents or to drugs with similar chemical structure,
- •Participation of the patient in another clinical trial within the last 4 weeks before the inclusion
- •addiction or other disorders that do not allow the concerned person, to assess the nature and scope and possible consequences in the clinical investigation
- •pregnant or breast feeding women
- •women of childbearing potential, except women who meet the following criteria:
- •post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH >40 U/ml)
- •postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy )
- •regular and proper use of a contraceptive method with error rate <1% per year (e.g., implants, depot injections, oral contraceptives, intrauterine device, IUD) during study treatment and up to 1 year after completion of therapy
- •sexual abstinence during study treatment and up to 1 year after completion of therapy
- •Vasectomy of the partner
- •Men who do not use one of the following types of effective contraception during study treatment and up to 1 year after completion of therapy:
- •sexual abstinence
- •State post-vasectomy
- •Evidence that the participating person is not expected to comply with the protocol (such as lack of cooperation)
- •Uncontrolled active infection
- •Severe hepatic impairment (AST and ALT may not exceed three times the normal) or liver cirrhosis or malignant liver tumor
- •Dialysis dependent renal dysfunction
- •Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease These criteria are not for the screening phase up to a known allergic reaction to azacitidine or intolerance to apply.
研究组 & 干预措施
Azacytidine
Experimental
Azacytidine injection: 75 mg/m²/d, subcutaneous
干预措施: Azacitidine (Drug)
结局指标
主要结局
Number of patients with hematological relapse 6 months after start of treatment with azacitidin
时间窗: 6 months after end of treatment
次要结局
- Rate of changes of methylation in CD34+ cells(2 years follow-up after treatment)
- Number of occurrence or exacerbation of clinical relevant acute or chronic GvHD(2 years follow-up after treatment)
- Relapse-free survival and overall survival(12, 24 and 30 months after start of treatment)
- Number of patients with infectious SAEs (rate of SAE)(2 years follow-up after treatment)
研究者
研究点 (11)
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