NCT00326157已完成2 期
Phase II Pilot Study on Safety of Administration of 3mg/kg/Day Three Times a Week Until Day 22 (21 Days After Transplantation Day) and 7 mg/kg Weekly From Day 29 to the End of Treatment (Day 50-8th Week) of AmBisome® in Antifungal Primary Prophylaxis Treatment of High Risk Patients Undergoing Allogeneic Stem-cell Transplantation
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
- 34
- 试验地点
- 1
- 主要终点
- Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
研究概览
简要总结
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of graft versus host disease (GvHD), which are both high risk periods as far as severe fungal infection development is concerned.
详细描述
This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome® loading dose regimen, in a weekly administration schedule during the initial phase of allogeneic stem-cell transplant and in case of occurrence of GvHD, which are both high risk periods as far as severe fungal infection development is concerned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or female patients aged more than 18 years
- •Patients with hematological malignancies undergoing allogeneic stem cell transplantation from donors other than human leukocyte antigen (HLA) identical sibling; source of stem cell includes either peripheral blood or bone marrow
- •No evidence of fungal infection at chest computed tomography (CT) scan and at sinus X-ray at baseline
- •Patients with no sign or symptoms of fungal infection and no previous proven or probable invasive fungal infection (IFI)
- •Females of childbearing potential must be surgically incapable of pregnancy, or practising a method of birth control, or agree to abstain from heterosexual intercourse while participating in the study, and with a negative pregnancy test (blood or urine) at baseline
- •An understanding of the study and agreement of the patient to give written informed consent
- •Ability and agreement to comply with all study requirements
- •Patient willing to attend hospital appointments for each injection (infusions will be performed in the hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in the hospital for at least one day, after the first infusion.
排除标准
- •Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B
- •Patients undergoing cord transplantation
- •Creatinine > 2.0 mg/dL
- •Patient with moderate or severe liver disease as defined by AST or ALT > 5 times the upper limit of normal (ULN)
- •Patients who are unlikely to survive more than 1 month
- •Patients who have received systemic antifungal therapy within 15 days prior to the inclusion
- •Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration
- •Any severe disease other than the hematological diseases described at the second point of inclusion criteria, which in the investigator's judgement may interfere with study evaluations or affect the patient's safety
- •Pregnant or nursing females
- •Patients previously included in this study
- •Patients who have taken any investigational drug in the last 30 days prior to the inclusion.
研究组 & 干预措施
1
Experimental
AmBisome® will be administered for a duration of 8 weeks
干预措施: AmBisome (Drug)
结局指标
主要结局
Safety and tolerability profile will be obtained by considering: Number (%) of patients with adverse events (AEs)
时间窗: Through 16 weeks
Number (%) of patients with infusion related AE
时间窗: Through 16 weeks
Laboratory parameters (in particular renal toxicity, hepatotoxicity, hypokalaemia, hypomagnesaemia)
时间窗: Through 16 weeks
Overall adverse events
时间窗: Through 16 weeks
次要结局
- Number (%) of patients with probable or proven invasive fungal infection according to EORTC-MSG criteria within the 6 months following the initiation of prophylaxis treatment(Within previous 6 months)
- Number (%) of patients with fever of unknown origin requiring empirical antifungal treatment within the 6 months following the initiation of prophylaxis treatment(Within previous 6 months)
- Number (%) of patients with superficial fungal infections within the 6 months following the initiation of prophylaxis treatment(Within previous 6 months)
- Number (%) of patients with evidence of colonization by fungal organisms observed within the 6 months following the initiation of prophylaxis treatment(Within previous 6 months)
- Reasons for early study discontinuation(Through 16 weeks)
- Survival rate and incidence of mortality related to fungal infection at the end of treatment and within 3, 6, and 12 months after the initiation of prophylaxis treatment(Within 12 months)
- Time to probable or proven invasive fungal infection; fever of unknown origin requiring empirical antifungal treatment(Through 16 weeks)
- Time to superficial fungal infections(Through 16 weeks)
- Time to initiation of empirical antifungal treatment(Through 16 weeks)
- Time to study discontinuation(Through 16 weeks)
- Number of patients enrolled(Through 16 weeks)
- Number of patients completing the study(Through 16 weeks)
- Number of patients with early discontinuation(Through 16 weeks)
- Number of patients classified by reason for discontinuing study drug (including the study completion)(Through 16 weeks)
研究者
研究点 (1)
Loading locations...
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