A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
研究概览
简要总结
In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:
- T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)
- Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma
- Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.
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
- •Have measurable lesions
- •Have recovered from prior chemotherapies
- •Have an estimated life expectancy of at least 12 weeks
- •Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present)
- •Renal: serum creatinine less than or equal to 1.5XULN
- •Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria:
- •Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation).
- •Anti-lymphoma therapy within the past 3 weeks
- •Unable to swallow tablets
- •Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment
排除标准
- 未提供
研究组 & 干预措施
T-Cell
T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
干预措施: enzastaurin (Drug)
Indolent B-Cell
Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
干预措施: enzastaurin (Drug)
Aggressive B-Cell
Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
干预措施: enzastaurin (Drug)
结局指标
主要结局
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
时间窗: Baseline to Measured Progressive Disease (Up to 114 Months)
Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value \> 50% decrease from baseline \[for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).
次要结局
- Progression Free Survival (PFS)(Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months))
- Duration of Response (DOR)(Baseline to Measured Progressive Disease (Up to 97 Months))
- Number of Participants With One or More Drug-Related Adverse Events(Baseline to End of Study (Up to 114 Months))
- Time to Progressive (TTP) Disease(Baseline to Measured Progressive Disease (Up to 114 Months))
- Percentage of Participants With Progression Free Survival (PFS) at 1-Year(Baseline to Measured Progressive Disease or Death From Any Cause (1 Year))