A Multicenter, Single-arm Phase II Study to Evaluate the Efficacy and Safety of Bendamustine Hydrochloride Injection in Subjects With Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 11
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
This is a study to evaluate the efficacy and safety of Bendamustine Hydrochloride Injection in subjects with Rituximab-resistant Indolent B-Cell Non-Hodgkin's Lymphomas.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inert lymphoma, including follicular lymphoma (FL), extranodal marginal zone B-cell lymphomas of the mucosa-associated lymphoid tissue (MALT), lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocyte B-cell lymphoma and chronic lymphoblastic leukemia (CLL).
- •At least one measurable lesion with the longest diameter > 1.5 cm and the short diameter > 1.0 cm, or the peripheral blood B lymphocyte ≥ 5.0×109/L.
- •3.Adequate laboratory indicators.
- •Has received one to three chemotherapy regimens (with or without rituximab) before enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Understood and signed an informed consent form.
排除标准
- •Patients who could not tolerate bendamustine treatment according to the investigators' judgment.
- •Has received anti-tumor treatment (including major surgery) in the last 4 weeks.
- •Transformed into high malignant lymphoma (secondary to low-grade follicular lymphoma); grade 3B follicular lymphoma.
- •Has received corticosteroids regularly in the last 4 weeks.
- •Has a history of central nervous system disease or central nervous system disease.
- •Has other tumors.
- •Has suffered from serious infection and other drugs or mental illness,which affects signing informed consent form and follow-up visit.
- •Pregnant or breastfeeding women.
- •Has participated in other clinical trials within three months.
研究组 & 干预措施
Bendamustine hydrochloride injection
Bendamustine hydrochloride injection 120 mg/m² or 100 mg/m² intravenously (IV) on Day 1 and Day 2 of 21-day cycle (6-8 cycles maximum) for non-hodgkin's lymphomas or chronic lymphocytic leukemia. After 6-8 cycles, the course of treatment could be added based on patient's benefit and investigator's determination.
干预措施: Bendamustine hydrochloride injection (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: Baseline up to 30 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
Duration of Response (DOR)
时间窗: Baseline up to 30 weeks
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
次要结局
- Progression Free Survival (PFS)(Baseline up to 30 weeks)
- Overall Survival (OS)(Baseline up to 30 weeks)