Phase I/II Study of Ruxolitinib Plus L-asparaginase, Vincristine, and Prednisone in Adult Patients With Relapsed or Refractory Early T Precursor Acute Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 主要终点
- Establish optimal dose of ruxolitinib
研究概览
简要总结
To determine the maximum tolerated dose (MTD), if present, and dose schedule of ruxolitinib in combination with L-ASP, vincristine, and prednisone (LVP) in patients with relapsed-and-refractory (R/R) early T precursor acute lymphocytic leukemia (ETP-ALL). Once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with LVP in patients with R/R ETP-ALL.
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
- 年龄范围
- 13 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with early T-precursor ALL, with any of the following:
- •refractory to primary induction therapy or refractory to salvage therapy,
- •in untreated first relapse with first remission duration <12 months
- •in untreated second or greater relapse
- •relapse at any time after allogeneic HSCT
- •Subject has received intensive combination chemotherapy for the treatment of ALL for initial treatment or subsequent salvage therapy.
- •Greater than 5% blasts in the bone marrow
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
排除标准
- •Malignancy other than ALL within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease
- •Current relevant central nervous system (CNS) pathology or known or suspected CNS involvement
- •Isolated extramedullary disease
- •Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •Autologous HSCT within 6 weeks or allogeneic HSCT within 12 weeks before blinatumomab treatment, or eligibility for allogeneic HSCT at the time of enrollment
- •Active acute grade 2 to 4 graft versus host disease (GvHD) according to Glucksberg et al (1974) criteria that required systemic treatment to prevent or treat GvHD 2 weeks before blinatumomab treatment
- •Known exclusion criteria to investigator choice of SOC chemotherapy (per package insert)
- •Cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included CD19 therapy) within 4 weeks of protocol-specified therapy
- •Abnormal laboratory values (alanine or aspartate transaminase [ALT or AST] or alkaline phosphatase [ALP] ≥ 5 × upper limit of normal [ULN]; total bilirubin or creatinine ≥ 1.5 × ULN), or calculated creatinine clearance < 60 mL/min.
研究组 & 干预措施
ruxolitinib, vincristine, prednisone
Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
干预措施: Ruxolitinib (Drug)
ruxolitinib, vincristine, prednisone
Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
干预措施: Vincristine (Drug)
ruxolitinib, vincristine, prednisone
Open label dosing cohorts will evaluate oral ruxolitinib (doses ranging from 10 - 80 mg) in combination with vincristine (1.4 mg/m2) and oral prednisone (1 mg/kg, 5 days a week for 4 weeks).
干预措施: Prednisone (Drug)
结局指标
主要结局
Establish optimal dose of ruxolitinib
时间窗: Upon completion of a 28 day treatment cycle
Determine maximum tolerated dose (MTD) of ruxolitinib
次要结局
- Overall response(At the end of Cycle 2 (each cycle is 60 days))
- Evaluate safety by assessing toxicities(Upon completion of a 28 day treatment cycle)
- Complete response(At the end of Cycle 2 (each cycle is 60 days))
研究者
Jie Ji
Clinical Professor
Sichuan University