A Multi-Center, Open-Label, Phase II Study of Sequential, Single-Agent Obatoclax Mesylate (GX15-070MS)Followed by a Combination With Rituximab to Patients With Previously-Untreated Follicular Lymphoma (FL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.
详细描述
This is a multi-center, open-label, Phase II study of obatoclax administered alone as a weekly, 3-hour or 24-hour infusion for 12 weeks followed by a combination with rituximab to patients with previously-untreated Follicular Lymphoma. For purposes of clinical evaluations, treatment cycles will occur in 4-week periods. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
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
- •Pathological confirmation of Follicular Lymphoma (FL)
- •Must have advanced stage disease
- •Must not have received any prior chemotherapy or immunotherapy for lymphoma, including steroids
- •Must have adequate organ function
- •Must have the ability to understand and willingness to sign a written informed consent form
排除标准
- •No other agents or therapies administered with the intent to treat malignancy
- •Uncontrolled, intercurrent illness
- •Pregnant women and women who are breast feeding
研究组 & 干预措施
Obatoclax mesylate 40mg
40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
干预措施: Obatoclax mesylate (Drug)
Obatoclax mesylate 40mg
40 mg over 3 hrs q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
干预措施: Rituximab (Drug)
Obatoclax mesylate 60mg
60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
干预措施: Obatoclax mesylate (Drug)
Obatoclax mesylate 60mg
60 mg obatoclax mesylate over 24 hours, q/weekly for 12 weeks, 4 weeks combo with rituximab, another 8 weeks single-agent obatoclax
干预措施: Rituximab (Drug)
结局指标
主要结局
Response rate
时间窗: 12 weeks
次要结局
- Time to Tumor Progression.(20 weeks)