Phase 1, Open-Label, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered in Combination With Rituxan (Rituximab) in Subjects With B-Cell Non Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events through 1 month after completing treatment
研究概览
简要总结
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with rituximab is safe for patients with non-Hodgkin's lymphoma (NHL).
详细描述
This is a Phase 1 open-label dose-escalation study of rituximab + rIL-21 combination therapy, administered once weekly for 4 weeks following an initial treatment with one dose of rituximab alone to patients with B-cell non-Hodgkin's lymphoma (NHL) who have failed prior therapy(ies). A standard dose of rituximab will be used. Increasing doses of rIL-21 will be studied sequentially in different groups of patients, starting with 30 μg/kg.
Before starting treatment with rituximab + rIL-21, patients will be treated with one dose of rituximab alone to look for rituximab infusion-related symptoms (such as fever, chills, and rigors). Patients who have severe infusion-related side effects after the first dose of rituximab will not go on to receive IL-21. Those who do not have unacceptable rituximab-related side effects will receive intravenous rIL-21 at least 60 minutes after completing the rituximab infusion at the rest of the weekly dosing visits. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed 2 weeks following completion of the first 4-week treatment cycle. Patients with stable disease or better at this evaluation may go on to receive a second 4-week treatment cycle of rituximab + rIL-21. Patients may be in the study for 2 to 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CD20+ B-cell NHL
- •Disease measurable by computed tomography (CT) scan
- •Has failed at least one prior systemic therapy for NHL
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hepatic and renal function
- •Adequate bone marrow function
排除标准
- •Presence of acute infection or other significant systemic illness
- •White blood cell (WBC) count > 50,000/mm3 in peripheral blood
- •Central nervous system involvement by malignancy
- •Previous allogenic transplant or autotransplant within 6 months of enrollment
- •Other current malignancy or known history of cancer within 5 years
- •Received systemic corticosteroids, chemotherapy, immunotherapy, biologic therapy, antibody therapy (e.g., rituximab), radiation therapy, and/or investigational agent(s) within 1 month of enrollment
结局指标
主要结局
Incidence and severity of adverse events through 1 month after completing treatment
时间窗: During treatment and through 1 month after completing treatment
Incidence and grade of clinical laboratory abnormalities through 1 month after treatment
时间窗: During treatment and through 1 month after completing treatment
次要结局
- Disease response by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas 2 weeks after completion of the first treatment cycle(Two and four weeks after completion of the first and second cycles, respectively)
- Immunogenicity by incidence of anti-rIL-21 antibodies up to 1 month after treatment(During treatment and up to 1 month after completing treatment)