NCT00289562已完成1 期
A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients With B-Cell Acute Lymphoblastic Leukemia With an Option of Extended Use of Forodesine Hydrochloride
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 7
研究概览
简要总结
A Phase I/II, Multi-Center, Open-Label, Repeat-Dose Study of Forodesine Hydrochloride Infusion in Patients with B-cell Acute Lymphoblastic Leukemia with an Option of Extended Use of Forodesine Hydrochloride
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented B-cell acute lymphoblastic leukemia (B-ALL), which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
- •Must have failed at least 1 treatment regimen for B-ALL, which under WHO Guidelines is now referred to as precursor B-lymphoblastic leukemia/lymphoma
- •Performance status of ≤2 by Eastern Cooperative Oncology Group (ECOG) criteria
- •Any age is allowed
- •Life expectancy of at least 3 months
- •Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits of normal [ULN])
- •Adequate kidney function (calculated creatinine clearance >40 mL/min)
- •Negative serum or urine pregnancy test within 2 to 7 days prior to the start of study treatment in females of childbearing potential
- •Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- •Signed informed consent form (ICF), minor assent form (if applicable), prior to start of any study-specific procedures
排除标准
- •Active serious infection not controlled by oral or intravenous antibiotics
- •Treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given
- •Rapidly progressive disease with compromised organ function judged to be life-threatening by the Investigator
- •Patients with clinical evidence of active central nervous system (CNS) disease
- •Concurrent treatment with other anticancer agents
- •Pregnant and/or lactating female
- •Patients with known human immunodeficiency virus (HIV) infection HIV testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
- •Patients with known active hepatitis B and/or hepatitis C infection Hepatitis testing will be performed at the Screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened.
- •Hypersensitive or intolerant to any component of the study drug formulation
研究者
研究点 (7)
Loading locations...
相似试验
终止
2 期
Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment RegimensLeukemiaLymphomaNCT00419081BioCryst Pharmaceuticals100
终止
1 期
Trial of Forodesine in Patients With Relapsed B-cell Chronic Lymphocytic LeukemiaB-cell Chronic Lymphocytic LeukemiaNCT00646165Mundipharma Research Limited1
已完成
2 期
Study of Forodesine Hydrochloride in Patients With Advanced, Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)Leukemia, Lymphocytic, ChronicNCT00289549BioCryst Pharmaceuticals8
进行中（未招募）
不适用
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma - Forodesine in CTCPrimary Cutaneous T-cell Lymphomas (CTCL)MedDRA version: 9.1Level: LLTClassification code 10028483Term: Mycosis fungoidesEUCTR2007-002093-60-ITBIOCRYST PHARMACEUTICALS INC.150
进行中（未招募）
不适用
Single agent phase II study of Forodesine (BCX1777) in the treatment of cutaneous T-Cell Lymphoma - forodesine in CTCEUCTR2007-002093-60-ATBioCryst Pharmaceuticals, Inc.150