Phase 2 Study of Canfosfamide HCl for Injection (Telcyta®, TLK286)in Refractory or Relapsed Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.
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
- •relapsed or refractory disease
- •histologically or cytologically confirmed disease
- •characteristic immunophenotypic profiles
- •measurable disease (for lymphoma patients)
- •ECOG performance status of 0-2
- •adequate liver and kidney function
- •adequate bone marrow reserves
- •ineligible or unwilling to undergo autologous stem cell transplantation
排除标准
- •failure to recover from any major surgery within 4 weeks of study entry
- •pregnant or lactating women
- •women of child-bearing potential not using reliable and appropriate contraception
- •routine prophylactic use of G-CSF required within 2 weeks of study entry
- •Grade 3 or higher peripheral neuropathy
- •history of hepatitis B virus or HIV
- •central nervous system or meningeal involvement by lymphoma or multiple myeloma
研究组 & 干预措施
Mantle Cell Lymphoma
Patients with relapsed or refractory mantle cell lymphoma
干预措施: Canfosfamide HCl for injection (Drug)
Diffuse Large B Cell Lymphoma
Patients with relapsed or refractory diffuse large B cell lymphoma
干预措施: Canfosfamide HCl for injection (Drug)
Multiple Myeloma
Patients with relapsed or refractory multiple myeloma
干预措施: Canfosfamide HCl for injection (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: At 24 weeks of treatment
Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.
次要结局
- Duration of Response(At 6, 12, 18 & 24 weeks of treatment)
- Safety Assessments(At 3, 6, 9, & 12 weeks of treatment)