Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Overall response rate(objectives (ORR)
研究概览
简要总结
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic Leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo untreated ALL patients diagnosed by the bone marrow morphology, immunophenotype.
- •65 ≥ Age (years) ≥ 18 , male or female,
- •ECOG Performance status of 0, 1, or
- •Patients must fulfill the following laboratory values
- •Total bilirubin ≤2 ULN (corrected for same age)
- •AST and ALT ≤3 ULN ( corrected for same ages)
- •Serum creatinine ≤2 ULN (corrected for same age)
- •Didn't receive any of the following treatments within 4 weeks before inclusion: chemotherapy, radiotherapy, replacement therapy, operation, long term of glucocorticoid therapy（>5 days）.
- •No neurological disorders, no nerve or muscle injury (motor and sensory nerve).
- •Patient must sign the informed consent and obey the protocol.
排除标准
- •Atopy or allergic to multiple medicines or excipients.
- •With serious complications that affect compliance.
- •Serious organ dysfunctions or central nervous system disorders.
- •Mixed phenotype acute leukemia, (T-B).
- •Burkitt lymphoma/leukemia.
- •Suspected or confirmed central nervous system leukemia.
- •Diabetes.
- •Received antifungal treatment with triazole agents within 1 month before inclusion.
- •Reliance of antipyretic and analgesic medicines or psychotropic medicines.
- •Undergoing or has undergone other clinical trials in 4 weeks before inclusion.
- •Pregnant women, women of breast feeding or childbearing potential without contraception.
- •Psychological disorders that affect signing consent.
- •The investigators believe that patients who are not suitable for inclusion.
研究组 & 干预措施
Vincristine Sulfate Liposome
Vincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22.
Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection.
干预措施: Vincristine Sulfate Liposome (Drug)
Vincristine Sulfate
Vincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22.
Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent.
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
Overall response rate(objectives (ORR)
时间窗: up to 35 days
ORR=CR+CRi CR(Complete response) 1. No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement 2. Trilineage hematopoiesis(TLH)and \<5% blast in bone marrow 3. ANC\>1000/microl 4. Platelets\>100,000/microl CRi(Complete response with incomplete recovery of counts) Recovery of platelets but\<100,000 or ANC is \<1000/microl
Incidence of General peripheral neuropathy
时间窗: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy
Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc). If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs.
次要结局
未报告次要终点