EUCTR2015-002526-39-Outside-EU/EEA进行中（未招募）不适用
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects with Acute Leukemias Undergoing Myeloblative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •1.ALL or AML requiring HSCT
- •2.Age = 1 and = 16 years at screening
- •3.Lansky performance status > 60%
- •4.Candidate for allogeneic HSCT protocol:
- •Adequate kidney function: Serum creatinine: = 1.5 mg/dL or creatinine clearance or radioisotope GFR = 60 mL/min/1.73m2
- •Adequate liver function: Serum total bilirubin: = 2.0 mg/dl; AST/ALT = 4.0 x institutional upper limits of normal (IULN); Albumin = 2 g/dL
- •Adequate cardiac function: shortening fraction > 29% documented by echocardiogram, or ejection fraction = 50% documented by multigated acquisition scan (MUGA).
- •Adequate pulmonary function documented by corrected DLCO > 50% or oxygen saturation of
- •= 92% on room air if unable to perform pulmonary function tests
- •Negative for human immunodeficiency virus (HIV), hepatitis C virus (HCV), human T cell lymphotropic virus (HTLV)
- •5.Identification of an HLA-compatible donor per institutional standards
- •6.Assent from a minor (if the child is capable of giving assent) per Department of Health and Human Services (DHHS) guidelines listed in 21CFR 50.55 and local IRB standards.
- •7.Serum amylase and lipase: = 1.2 x IULN
- •8.Negative serum/urine pregnancy test for females with childbearing potential within 4 days before administration of the first palifermin dose
- •9.Agreement by males and females of reproductive potential to use an effective means of contraception 30 days prior to enrollment through Day +30 (end of treatment)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 54
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior treatment with palifermin or other keratinocyte growth factors
- •2.Received an investigational product or device, with the exception investigational stem cell separators, in another clinical trial within 30 days before enrollment.
- •3.Known to have a life threatening infection not responding well to treatment
- •4.Past history of veno-occlusive disease of the liver
- •5.Known sensitivity to any Escherichia coli-derived products with grade 3 to 4 allergies to
- •L-asparaginase [grade 1 to 2 allergies to
- •L-asparaginase will be allowed].
- •6.Receiving glutamine or any other medication to reduce the incidence of OM within 30 days before enrollment
- •7.Previous or concurrent malignancy other than entry diagnostic criteria and/or solid organ transplantation and/or treatment of congenital immunodeficiency
- •8.History of pancreatitis
- •9.Breastfeeding (giving)
研究者
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