NCT00436280已完成2 期
An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
研究概览
简要总结
The primary purpose of this study is to help answer the following research questions:
- To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer.
- To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
- To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
- To look at the level of enzastaurin in the body and how long it remains.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent lymphoma
- •Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (SD) obtained in 1st- or 2nd-line.
- •Measurable disease (lymph node greater than 1.5 cm)
- •Adequate organ function
- •Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)
排除标准
- •Prior Allogeneic transplantation
- •More than 2 prior anticancer treatment regimens
- •Pregnant or breastfeeding
- •Human-immunodeficiency-virus (HIV)associated lymphomas
- •Brain metastases
研究组 & 干预措施
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Experimental
干预措施: gemcitabine (Drug)
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Experimental
干预措施: enzastaurin (Drug)
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Experimental
干预措施: rituximab (Drug)
Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
Experimental
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Percent of Participants With Progression Free Survival (PFS) After 1 Year Treatment
时间窗: First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 1 Year
PFS is defined as the rate at 1 year from the date of first dose of study drug to the first date of measured PD or death from any cause and was determined using the distribution of overall PFS times. The PFS rate at 1 year was determined using Kaplan-Meier estimates. For participants not known to have died as of the data cut-off date and who do not have PD, PFS was censored at the date of the last progression-free disease assessment.
次要结局
- Overall Response Rate (ORR) - Percentage of Participants Achieving Complete Response (CR) or Complete Response Unconfirmed (CRu) or Partial Response (PR) (Response)(Baseline to Measured Progressive Disease or Death from Any Cause at End of 4 and 8 Cycles)
- Percent of Participants With Progression-Free Survival (PFS) After 2 Years and 4 Years of Treatment(First Dose of Study Drug to Measured Progressive Disease or Death from Any Cause at 2 Years, 4 Years)
- Percent of Participants With Overall Survival (OS) After 1 Year, 2 Years and 4 Years(First Dose of Study Drug to Death from Any Cause at 1 Year, 2 Years and 4 Years)
- Percent of Participants With Event Free Survival (EFS) After 1 Year, 2 Years and 4 Years(First Dose of Study Drug to Measured PD, or Start of New Lymphoma Treatment or Death from Any Cause at 1 Year, 2 Years and 4 Years)
- Progression-Free Survival (PFS ) of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-Center B-cells (GCB) Versus Non-GCB Molecular Subtypes (Assessment of Biomarkers Relevant for Enzastaurin)(Baseline, Cycles 1-4, End of Study)
- PFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C Beta 2 (PKCB2) Expression (Assessment of Biomarkers Relevant for Enzastaurin)(Baseline, Cycles 1-4, End of Study)
- Pharmacokinetics (PK): Maximum Observed Drug Concentration During a Dosing Interval at Steady State(Cmax,ss) for Total Analyte [Characterization of Pharmacokinetics of Enzastaurin and Its Metabolites](Day 2 of Cycle 2: Predose;1-2 Hours(H);3-4 h;5-6 h;7-8 H Postdose)
- PK: Area Under the Concentration vs. Time Curve During 1 Dosing Interval at Steady State (AUCτ,ss) for Total Analyte(Day 2 of Cycle 2: Predose;1-2 hours(h);3-4 h;5-6 h;7-8 h Postdose)
- Percent of Participants With Disease-Free Survival (DFS) at 1 Year, 2 Years and 4 Years(First Dose of Study Drug to Relapse after CR or CRu or Death from any Cause at 1 Year, 2 Years and 4 Years)
- Duration of Tumor Response (DOR)(Time from Observed CR and CRu or PR (Up to 4 Years))
研究者
研究点 (1)
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