A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 24
- 主要终点
- Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
研究概览
简要总结
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.
详细描述
BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
- •Failure to have responded to one or more standard regimens for their disease.
- •Performance status of <=2 by Eastern Cooperative Oncology Group (ECOG) criteria
- •All ages are eligible
- •Life expectancy of at least 3 months
- •Adequate liver function (aspartate transaminase [AST] and/or alanine transaminase [ALT] not >3 times upper limits or normal [ULN])
- •Adequate kidney function (calculated creatinine clearance >50 mL/min)
- •Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment 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
- •Signed informed consent/assent form (ICF) prior to start of any study specific procedures
排除标准
- •Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
- •Patients with known Hepatitis B and/or Hepatitis C active infection
- •Patients with active CMV infection
- •Tumor-related central nervous system (CNS) leukemia requiring active treatment
- •Active serious infection not controlled by oral or IV antibiotics
- •Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
- •Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
- •Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
- •Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
- •Pregnant and/or lactating women
结局指标
主要结局
Determine the sustained effectiveness of IV forodesine hydrochloride infusions in patients with advanced T-cell leukemia (T-ALL or T-PLL)
次要结局
- Safety and tolerability
- Pharmacokinetics (PK) and Pharmacodynamics (PD)
- maintenance of response and safety in long-term treatment