EUCTR2005-004495-21-DE进行中（未招募）不适用
Pilot study on safety of four weekly administrations of 7 mg/kg of liposomal amphotericin B (AmBisome®) in antifungal primary prophylaxis treatment ofelderly patients with acute lymphoblastic leukemia undergoing induction chemotherapy within the GMALL-Elderly protocol. - ProphyA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or female patients
- •Patients with ALL undergoing first induction chemotherapy within the GMALL-Elderly
- •1/2003 protocol
- •Females of childbearing potential (less than 2 years post-menopausal) must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline
- •Understanding of the study's rational and procedures documented in the patient's
- •informed consent
- •Ability and agreement to comply with all study requirements
- •Patient willing to attend hospital appointments for each visit (infusions will be performed in hospital, under strict medical supervision)
- •Written informed consent must be obtained before any study protocol-related
- •procedure is carried out
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersensitivity to amphotericin B or LAMB or any of its constituents, in
- •particular known history of anaphylactic reaction to amphotericin B or LAMB or any of
- •its constituents
- •Signs or symptoms of IFI or previous proven or probable IFI in the medical history
- •Evidence for pulmonary infiltrates in chest CT and/or x-ray of the chest, (only when a chest CT/x-ray is done at baseline)
- •Estimated creatinine clearance (ECC) = 60 mL/min (Cockcroft-Gault); in such cases the body surface adjusted Modification Diet in Renal Disease (MDRD) glomerular filtration rate (GFRMDRD) should be calculated. If the body surface adjusted GFRMDRD is above 60 mL/min, the patient can be included
- •Patient with moderate or severe liver disease as defined by AST, ALT or alkaline
- •phosphatase (AP) > 5 times the upper limit of normal (ULN), or bilirubin > 3 times ULN
- •Patients who are unlikely to survive more than 1 month
- •Febrile patients (= 38.5°C)
- •Patients who have received systemic antifungal therapy within 15 days prior to the
- •Any severe co-morbidity other than the underlying hematological disease (ALL), which in the investigator's judgment may interfere with study evaluations or affect the patient's safety
- •Patients previously included in this study
- •Patients who have taken any investigational drug within the last 30 days prior to the inclusion except drugs used according to the GMALL-Elderly/2003 protocol
- •Patients who participate in another clinical trial except anti-cancer trials
研究者
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