A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients With Non Hodgkin's B-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- selected dose of aflibercept based on Dose Limiting Toxicities observed
研究概览
简要总结
The purpose of this study is to determine the selected dose of aflibercept when it is combined with R-CHOP treatment (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate) administered every 2 weeks or every 3 weeks, in non Hodgkin B-cell lymphoma, and to determine how the body handles aflibercept when it is administered with R-CHOP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-Hodgkin B-cell lymphoma, good condition, not previously treated
排除标准
- •Contraindication to any drug contained in the R-CHOP (Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone +/- intrathecal Methotrexate)
- •Less than 42 days elapsed from prior major surgery (28 days from other prior surgery) to the time of inclusion
- •Cerebral or leptomeningeal involvement.
- •History of another neoplasm (Adequately treated basal cell or squamous cell skin cancers, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease free for > 5 years are allowed)
- •Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to the first drug intake
- •Any acute or chronic medical condition, which could impair the ability of the patient to participate to the study or could interfere with interpretation of study results
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •Abnormal kidney function
- •Evidence of clinically significant bleeding diathesis, non-healing wound or underlying coagulopathy
- •Pregnant or breast-feeding woman, or patient with reproductive potential (male, female) without an effective method of contraception
- •History of hypersensitivity to any Trap agents or recombinant proteins
研究组 & 干预措施
Aflibercept RCHOP 14
Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 2 weeks. A dose of 2.0 mg/kg administered as Dose Level 1, 4.0 mg/kg as Dose Level 2, and 6.0 mg/kg dose as Dose level 3.
干预措施: aflibercept (Drug)
Aflibercept RCHOP 21
Aflibercept (25 mg/ml by IV over an hour) in combination with fixed dose of rituximab (R), cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) administered every 3 weeks. A dose of 3.0 mg/kg administered as Dose Level 1, 6.0 mg/kg as Dose Level 2, and 8.0 mg/kg dose as Dose level 3.
干预措施: aflibercept (Drug)
结局指标
主要结局
selected dose of aflibercept based on Dose Limiting Toxicities observed
时间窗: cycle 1 +/- 2
次要结局
- Adverse events(treatment period)
- Response rate(cycle 2, 4 and 8)
- Progression free survival(study period)
- Biomarkers(Study period)