Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Complete Remission
研究概览
简要总结
This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
- •For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (</=) 6
- •Binet stage B, C or A with progression
- •Life expectancy greater than or equal to (>/=) 12 months
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion
排除标准
- •Participants with small-cell lymphoma
- •Participants with auto-immune hemolytic anemia
- •Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
- •Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
- •Participants with Richter's Syndrome
- •Participants with symptomatic Hepatitis B infection
- •Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
- •Creatinine clearance less than (<) 30 milliliters per minute (mL/min)
- •Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
- •Participants with liver failure and acute hepatitis of any etiology
- •Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
- •History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
- •Pregnancy and breast-feeding women
研究组 & 干预措施
Rituximab + Fludarabine + Cyclophosphamide
Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
干预措施: Cyclophosphamide (Drug)
Rituximab + Fludarabine + Cyclophosphamide
Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
干预措施: Fludarabine (Drug)
Rituximab + Fludarabine + Cyclophosphamide
Participants received rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration was 6 cycles, 28 days each.
干预措施: Rituximab (Drug)
结局指标
主要结局
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 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 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
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%.
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%.
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.
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.
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 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.
次要结局
未报告次要终点