Prospective Randomized Study to Compare Efficacy and Safety of RFC-Lite (Rituximab, Fludarabine, Cyclophosphamide) Regimen With LR (Rituximab, Chlorambucil) as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Event-free Survival
研究概览
简要总结
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously [IV] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients, 60-70 or >70 years of age
- •Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70 years old
- •Previously untreated B-cell chronic lymphocytic leukemia
- •Binet stage B, C or A with progression
- •ECOG performance status 0-2
排除标准
- •Small-cell lymphoma
- •Autoimmune hemolytic anemia
- •Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
- •Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
- •Richter's syndrome
研究组 & 干预措施
LR Therapy
Rituximab and chlorambucile
干预措施: Rituximab (Drug)
FCR-lite
Rituximab, fludarabine, and cyclophosphamide
干预措施: Cyclophosphamide (Drug)
FCR-lite
Rituximab, fludarabine, and cyclophosphamide
干预措施: Fludarabine (Drug)
FCR-lite
Rituximab, fludarabine, and cyclophosphamide
干预措施: Rituximab (Drug)
LR Therapy
Rituximab and chlorambucile
干预措施: Chlorambucil (Drug)
结局指标
主要结局
Event-free Survival
时间窗: Up to approximately 5 years
Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by \>50%.
Percentage of Participants With Complete Remission
时间窗: Up to approximately 5 years
Complete remission was defined as the disappearance of all signs of disease.
Percentage of Participants With Stable Disease
时间窗: Up to approximately 5 years
Stable disease was defined as not meeting the criteria for partial remission or disease progression
Duration of Response
时间窗: Up to approximately 5 years
Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by \>50%.
Progression-free Survival
时间窗: Up to approximately 5 years
Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Percentage of Participants With Disease Progression
时间窗: Up to approximately 5 years
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Percentage of Participants With Phenotypic Remission
时间窗: Up to approximately 5 years
Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.
Percentage of Participants With Partial Remission
时间窗: Up to approximately 5 years
Partial remission was defined as a reduction in tumor size by \>50%.
Overall Survival
时间窗: Up to approximately 5 years
Overall survival was defined as the time period from the first day of study treatment to participant death.
Percentage of Participants With Adverse Events (AEs) and Serious AEs
时间窗: Up to approximately 5 years
An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.
次要结局
未报告次要终点