Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
详细描述
PRIMARY OBJECTIVES:
I. To determine the complete remission (CR) rate and progression-free survival following treatment with hyperfractionated cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (hyper-CVAD) in combination with nelarabine in previously untreated patients with T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma.
II. To determine the safety and overall survival of previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma.
III. To determine the safety and efficacy of adding pegaspargase to the regimen.
IV. To determine the safety and efficacy of adding venetoclax to the regimen.
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
- •Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =< 2 courses are also eligible
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
- •Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable
- •Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)
- •Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable
排除标准
- •Pregnant or nursing women
研究组 & 干预措施
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Vincristine Sulfate (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Cytarabine (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Venetoclax (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Cyclophosphamide (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Dexamethasone (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Doxorubicin Hydrochloride (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Mercaptopurine (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Pegaspargase (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Methotrexate (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Nelarabine (Drug)
Treatment (nelarabine and combination chemotherapy)
See Detailed Description
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall survival
时间窗: 3 years
Overall survival will be estimated.
Complete remission rate
时间窗: 3 years
The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.
Duration of remission
时间窗: Up to 9 years
Duration of remission will be evaluated.
Progression-free survival
时间窗: 3 years
Progression-free survival will be estimated.
次要结局
未报告次要终点