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临床试验/NCT03343600
NCT03343600终止2 期

A Randomization, Double Blind, Multicenter Phase II Clinical Trial to Evaluate the Imatinib for Prophylaxis of CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation

National Taiwan University Hospital5 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年11月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
5
试验地点
5
主要终点
Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.

研究概览

简要总结

This study aim at examining whether blocking platelet-derived growth factor receptor-α by imatinib lowers the risk of post-allogeneic hematopoietic stem cell transplantation CMV infection.

详细描述

This is a randomized, double-blind, multicenter phase II clinical trial. In the trial, post-allo-HSCT patients with signs of bone marrow engraftment and without evidence of CMV reactivation will be enrolled. All enrolled patients will be monitored for their blood CMV DNA copy numbers by Q-PCR and safety throughout the trial. In addition to their routine post-allo-HSCT care, eligible patients will receive imatinib (100mg/tablet, 2 tablets daily) or placebo (2 tablets daily) administration after myeloid engraftment (defined as absolute neutrophil count higher than 500 for three consecutive days). While receiving the trial therapy, patients will have a regular CMV surveillance every week by the quantification of plasma CMV DNA copies. During the administration of the investigational drugs, other concomitant anti-CMV prophylaxis treatments are prohibited. When a patient has any signs suggesting CMV infection that the treating physician determines that an anti-CMV therapy is indicated, the patient will be defined as failure of prophylaxis for the efficacy evaluation. Whether the conventional anti-CMV therapy is started or not, the investigational drugs with imatinib or placebo will be continued till at least Day+100 unless the patient is defined as prophylaxis failure or withdraws from the study including personal reasons, early mortality, disease recurrence after transplantation, pregnancy, or the investigator decides that the subject should be withdrawn for safety reasons or physical conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (Age ≧ 20) who received the first allo-HSCT are eligible;
  • Patients with underlying disease of acute leukemia in morphological remission, or myelodysplastic syndrome;
  • Received allo-HSCT with HLA-matched sibling or unrelated donors (at least 8/8 match for HLA-A/B/C/DR);
  • Evidence of post-transplantation neutrophil engraftment: absolute neutrophil count > 500/mm3 for at least 3 consecutive days;
  • No detectable CMV infection before study enrollment: negative plasma CMV DNA surveillance within passing 2 weeks;
  • No previous post-transplantation anti-CMV therapy and no planned prophylactic anti-CMV therapy;
  • The patients has the ability to swallow tablets

排除标准

  • They have renal insufficiency: serum creatinine > 2.5 mg/dL;
  • They have hepatic dysfunction: serum alanine or aspartate aminotransferase levels of > 5 times the upper limit of the normal range or a serum total bilirubin of > 3 mg/dL;
  • Patients with history of HIV infection;
  • Unstable post-BMT condition or other medical condition deemed not appropriate to be included to this study as judged by investigator;
  • Life expectancy less than 3 months;
  • Unwillingness or unable to give consent;
  • Patients with diseases that are positive for t(9;22) or BCR-ABL fusion gene.

研究组 & 干预措施

Imatinib

Experimental

Imatinib (100 mg/tablet) 2# per day till D+100 after allo-HSCT or prophylaxis failure.

干预措施: Imatinib (Drug)

Placebo

Placebo Comparator

Placebo 2# per day till D+100 after allo-HSCT or prophylaxis failure.

干预措施: Placebo (Drug)

结局指标

主要结局

Number of participants free from initiating conventional anti-CMV treatment by Day+100 after allo-HSCT.

时间窗: From first dosing to 100 days after allo-HSCT (Day+100)

Investigator determined whether anti-CMV treatment is needed or not based on clinical judgment no matter therapeutic or preemptive treatment. Symptomatic CMV infection or CMV organ disease was defined as described by Ljungman et al., 2002.

次要结局

  • Number of treatment-related adverse events (AE) by Day+100 after allo-HSCT.(From first dosing to 100 days after allo-HSCT (Day+100))
  • Time to onset of CMV reactivation defined by peripheral blood CMV copies by Day+100 after allo-HSCT.(From first dosing to 100 days after allo-HSCT (Day+100))
  • Number of participants who had progressive hematological disease within 6 months after allo-HSCT.(6 months post-transplant)
  • Time to onset of CMV disease diagnosed by investigator by Day+100 after allo-HSCT.(From first dosing to 100 days after allo-HSCT (Day+100))
  • Number of participants who died within 6 months after allo-HSCT.(6 months post-transplant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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