Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.
详细描述
OUTLINE:
- Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
- Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
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
- 17 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
RCVELP
Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):
-
Rituximab
-
Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
-
Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
-
Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
-
Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
-
Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
干预措施: Rituximab (Drug)
RCVELP
Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):
-
Rituximab
-
Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
-
Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
-
Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
-
Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
-
Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
干预措施: Bortezomib (Drug)
RCVELP
Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):
-
Rituximab
-
Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
-
Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
-
Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
-
Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
-
Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
干预措施: Cyclophosphamide (Drug)
RCVELP
Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):
-
Rituximab
-
Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
-
Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
-
Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
-
Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
-
Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
干预措施: Prednisone (Drug)
结局指标
主要结局
Overall Response Rate, According to the International Workshop Criteria (IWC) for Non-Hodgkin's Lymphoma (NHL)
时间窗: Post cycles 2,4,6,8 and then every 3 months, about 2 years
Rate of overall response (CR, CRu, PR) to protocol therapy according to International Workshop Criteria (IWC): * Complete Response (CR) includes complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL; * Complete Response Unconfirmed (CRu) includes above CR criteria but a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product of the perpendicular diameters (SPD), or indeterminate bone marrow; * Partial Response (PR) includes \>= 50% decrease in SPD of the six largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen.
次要结局
- Overall Survival (OS)(Up to 5 years)
- Progression-free Survival (PFS)(Up to 5 years)
- Rate of Toxicity in Study Participants(Up to 5 years)
研究者
Denise Pereira
Assistant Professor
University of Miami