Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 117
- 主要终点
- Time to treatment failure
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.
- Compare the efficacy and tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score [low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)]. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.
- Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.
Treatment continues every 4 weeks for 4-8 courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma
- •REAL classification grade I, II, or III
- •Treatment necessity indicated by presence of the following:
- •B symptoms
- •Bone marrow failure
- •Bulky or progressive disease
- •Compression syndromes
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •No autoimmune hemolytic anemia or active hemolysis
- •Direct Coombs' negative
- •Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)*
- •Bilirubin no greater than 2.5 times ULN* NOTE: *Unless attributable to lymphoma
- •Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)
- •Cardiovascular:
- •No severe cardiac failure
- •Ejection fraction at least 45%
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for at least 6 months after study
- •HIV negative
- •No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer
- •No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •No concurrent systemic corticosteroids
- •Radiotherapy:
- •Not specified
- •Not specified
- •No prior therapy
排除标准
- 未提供
结局指标
主要结局
Time to treatment failure
Progression-free survival rate
Overall survival rate
次要结局
- Clinical remission rate
- Molecular remission rate