Efficacy and Safety of Cladribine in Combination With G-CSF, Low-dose Cytarabine and Pegaspargase in Patients With Refractory/Relapsed Acute Lymphoblastic Leukemia: a Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CR rate
研究概览
简要总结
The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL.Our previous experience has shown that Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and Pegaspargase (C-GAP) in patients with refractory/relapsed acute Lymphoblastic Leukemia
详细描述
ALL is common in the elderly patients, who can not tolerate the intensified treatments. The vast majority of patients with ALL will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory ALL. Our previous experience has shown that Cladribine in combination of GAP(G-CSF priming, low dose cytarabine, and Pegaspargase) are effective with tolerable toxicity profiling.Thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with G-CSF, low-dose cytarabine and aclarubicin (C-CAG) in patients with refractory/relapsed acute myeloid leukemia.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women;
- •Clinical diagnosis of Relapsed/Refractory ALL;
- •ECOG performance status (PS) score 0-3;
- •AST and ALT <=2.5 times the institutional ULN;
- •Total bilirubin <=2.0 times the institutional ULN
- •Serum creatinine<2.0 times the institutional ULN;
- •Subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects;
- •Patients should understand the disease and voluntarily receive the study regimen and follow-up.
排除标准
- •Concurrent diagnosis of tumors other than ALL, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN);
- •Active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy;
- •Concurrent autoimmune hemolytic anemia or immune thrombocytopenia;
- •Subjects suffered from AIDS，active hepatitis B or C virus infection;
- •Dementia or altered mental status that would prohibit the understanding or rendering of informed consent;
- •Be allergic to any component of C-GAP regimen;
- •Subjects ever exposed to cladribine or CAG-based regimen.
研究组 & 干预措施
Cladribine group
Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm
干预措施: Cladribine (Drug)
Cladribine group
Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm
干预措施: G-CSF (Drug)
Cladribine group
Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm
干预措施: Cytarabine (Drug)
Cladribine group
Cladribine in combination of GAP (G-CSF priming, low dose cytarabine, and Pegaspargase) will be administrated in this arm
干预措施: Pegaspargase (Drug)
结局指标
主要结局
CR rate
时间窗: Bone marrow aspiration will be done within 2 weeks after blood cell count recovery (about 4 weeks after initiation of C-GAP treatment
Complete Remission: less than 5% blasts in bone marrow
次要结局
未报告次要终点
研究者
dr. luyue
professor
Sun Yat-sen University