NCT01252017已完成2 期
Cytomegalovirus (CMV) Reactivation in Post-allogeneic Hematopoietic Stem Cell Transplantation(Allo-HSCT) Patients: Salvage and Prophylactic Treatments of Nilotinib
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
- 36
- 试验地点
- 1
- 主要终点
- anti-CMV treatment free rate
研究概览
简要总结
The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.
详细描述
The purpose of this study is to determine whether nilotinib is effective in the prophylaxis and treatment of CMV reactivation in allo-HSCT patients.
Prophylaxis Part: patients will be treated with nilotinib after their hemogram engraftment to prevent CMV reactivation Salvage Part: patients who have had intractable CMV reactivation after gancyclovir therapy will be treated with nilotinib
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Adult patients who have received allo-HSCT
- •Performance status ECOG 0-2
- •Patients with CMV reactivation (defined as plasma CMV DNA copy numbers of more than 1000 copy numbers/ml by Quantitative-PCR) after allo-HSCT.
- •Patients with CMV reactivation that is uncontrollable by conventional first line agent (ganciclovir) for 2 or more weeks, or patients who are intolerable to ganciclovir treatment.
- •Adult patients who have received allo-HSCT
- •Performance status ECOG 0-2
- •Either the patient or his/her donor are CMV-IgG test positive
- •Patients with post-transplantation engraftment: stable myeloid engraftment (absolute neutrophil count 500/mm3) for at least 3 consecutive days, and stable megakaryocyte engraftment (platelet count 20k/uL) for at least 3 consecutive days.
- •Patient with no CMV reactivation before enrollment: a negative (undetectable) plasma CMV DNA Quantitative-PCR assay on blood collected within 7 days Patients without previous or current exposure to any prophylactic or therapeutic drugs for CMV reactivation
排除标准
- •Patients with renal insufficiency: serum creatinine > 2.5 mg/dL,
- •Patients with significant electrolyte deficiency after suitable supplement: [K] <3.0mmol/L, [Ca]< 2.0 mmol/L(corrected), or [Mg] < 0.6 mmol/L.
- •Patients with hepatic dysfunction: alkaline phosphatase ≥2.5 times of the upper normal limit of the normal range (ULN); serum alanine or aspartate aminotransferase levels of > 5 times ULN; a serum total bilirubin of > 3 mg/dL
- •Patients with serum amylase and lipase > 1.5 x ULN
- •Patients with history of HIV infection
- •Patients with unstable medical condition or any other history of serious/significant medical diseases deemed not appropriate to be included to this study as judged by investigators
- •Females patient who are pregnant or breast-feeding
- •Female patients of childbearing potential not using any reliable and appropriate contraception method(s)
- •Patients with life expectancy, as judged by the investigators, is less than 3 months
- •Patients with, as judged by the investigators, other contraindications of nilotinib administration, such as prolonged QTc, concurrent usage of drugs that possess possible severe drug-drug interactions with nilotinib, or had severe adverse effects in the previous exposure to nilotinib
- •Patients who cannot swallow capsules.
- •Patients who are unwilling or unable to give consent
研究组 & 干预措施
Nilotinib
Experimental
Single arm, open label study
干预措施: nilotinib (Drug)
结局指标
主要结局
anti-CMV treatment free rate
时间窗: 100 days after allo-HSCT (Day+100)
For prophylaxis part
次要结局
- Successful salvage rate(up to 8 weeks)
研究者
研究点 (1)
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