NCT01851551已完成1 期
A Phase I/II Study of Rituximab Plus Vincristine Sulfate Liposomes Injection in the Treatment of Relapsed or Refractory Aggressive Non Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Objective response rate
研究概览
简要总结
This was a Phase 1/2 study performed at two clinical centers in the US and UK. It was a single arm, open label study evaluating VSLI plus rituximab in adults with aggressive relapsed or refractory non-Hodgkin's lymphoma.
详细描述
The primary efficacy endpoint was objective response rate, defined as the proportion of patients with a response of CR + PR.
Duration of response, time to progression, and overall survival were analyzed. Descriptive statistics were used for demographics, disease characteristics, treatment exposures, efficacy, and safety variables.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined by the Revised European American Lymphoma/WHO classification. This included: diffuse large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or anaplastic large B-cell lymphoma. In the US protocol only, patients who had transformation from an indolent lymphoma and those who had mantle cell lymphoma were eligible.
- •Confirmation of CD20 expression on lymphoma cells.
- •Eastern Cooperative Oncology Group (ECOG) ≤
- •One or more prior chemotherapy regimens. Patients who had received prior rituximab therapy as part of an induction chemotherapy regimen or who had a previous response to rituximab as a single agent were eligible.
- •Measurable disease in at least 1 site, which had not been previously irradiated.
- •Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly defined margins that were ≥1.5 cm in the largest dimension determined by physical examination or computed tomography (CT) scan.
- •Total bilirubin and serum creatinine ≤2 times the ULN.
- •Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.
- •18 years of age or older.
- •Women of childbearing potential who were willing to use an acceptable method of contraception throughout the course of the study.
- •Signed and dated informed consent form.
排除标准
- •Known transformation from an indolent lymphoma (UK protocol only).
- •Eligible for conventional or high-dose chemotherapy with curative intent.
- •Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (>10 mg/day of prednisone or equivalent) within the past 4 weeks.
- •Any previous malignancies with less than a 5-year complete remission interval, except for curatively resected basal cell carcinoma or curatively resected in situ carcinoma of the uterine cervix.
- •History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe medical illness or infection.
- •History of neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
- •Grade 3 or 4 sensory or motor neuropathy at screening related to prior chemotherapy.
- •Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.
- •Pregnant or lactating women (women of childbearing potential underwent a pregnancy test).
- •Allergy to vincristine, or other vinca alkaloids.
- •Progressive disease while receiving or within 1 month of having received previous rituximab therapy (US protocol only).
- •Hypersensitivity to any component of rituximab or to murine proteins (UK protocol only).
研究组 & 干预措施
VSLI plus rituximab
Experimental
VSLI (vincristine sulfate liposome injection) plus rituximab
干预措施: Vincristine Sulfate Liposome Injection plus rituximab (Drug)
结局指标
主要结局
Objective response rate
时间窗: Assessed prior to each cycle for up to 12 cycles (24 weeks). For patients achieving a complete or partial response, follow-up assessments were to be made 2, 8, 16, and 24 weeks after treatment was discontinued (up to ~48 wks).
The primary efficacy endpoint was the objective response rate (ORR) defined as the proportion of patients whose best responses were complete response (CR) and partial response (PR) (ORR = CR + PR).
次要结局
- Overall survival(The interval between first dose and death due to any cause. Reported every 3 months post dose up to patient death. Follow up was approximately 2 years)
- Assessment of the number of events and number and percentage of patients with treatment-emergent AEs(AEs were assessed up to 30 days post last dose. Dosing may last up to 24 weeks.)
- Time to Progression(First dose to disease progression. Follow up was reported approximately every 3 months post-dose up to the date of patient death. Patients were followed up to 2 yrs.)
研究者
研究点 (2)
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