EUCTR2010-022388-37-DE进行中（未招募）1 期
Treatment of patients with MDS or AML with an impending hematological relapse with Azacitidin (Vidaza) - RELAZA2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
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 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 (CD34+/CD117+ positivity of blasts = 10% at any time prior to HSCT)
- •- MDS or AML without haematological relapse (blasts <5% in the bone marrow), and
- •- decrease of CD34+ or CD117+ donor chimerism (<80%) after allogeneic related or unrelated HSCT in CD34+ 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)
- •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 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
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:
- •o post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH> 40 U/ml)
- •o postoperative (6 weeks after hysterectomy with or without bilateral ovariectomy)
- •o 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
- •o sexual abstinence during study treatment and up to 1 year after completion of therapy
- •o 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:
- •o sexual abstinence
- •o 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.
研究者
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