A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Objective Response Rate
研究概览
简要总结
The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.
详细描述
Objectives:
Primary
- To estimate the objective response rate.
Secondary
- To assess the safety.
- To describe the progression-free survival at one year.
- To examine the association between clonal cytogenetic abnormalities identified by FISH, and the objective response rate as well as the progression-free survival at one year.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, newly diagnosed or relapsed MALT, marginal zone lymphoma, or low-grade B cell lymphoproliferative disorder which is CD5-, CD10- and CD20+
- •Pathology must be reviewed at Brigham & Women's Hospital, Massachusetts General Hospital, or the University of Rochester James P. Wilmot Cancer Center prior to enrollment
- •Documentation of CD20+ status
- •Must not be a candidate for local radiotherapy with curative intent
- •If gastric MALT, not a candidate for antibiotic therapy with curative intent
- •Patients with leukemic phase marginal zone lymphoma are eligible if their absolute lymphocyte count is >10,000 / µl
- •Prior treatment with rituximab is permitted, if rituximab induced an objective response which persisted for at least 6 months
- •Prior radiotherapy is acceptable
- •Measurable disease
- •ANC: > 1000/mm3
- •Platelets: > 100,000/mm3
- •Hemoglobin: > 7 gm/dL
- •Adequate renal function as indicated by serum creatinine <= 2 mg/dL.
- •Adequate liver function, as indicated by serum total bilirubin <= 2 mg/dL.
- •AST or ALT <3x Upper Limit of Normal unless related to primary disease.
- •Men and women of reproductive potential must agree to use an acceptable method of birth control during study treatment and for six months after completion of study treatment.
- •WHO Performance status </= 2
- •Subject has provided written informed consent.
排除标准
- •Patients with Waldenstrom's Macroglobulinemia or lymphoplasmacytic lymphoma are excluded
- •History of HIV
- •Active infection
- •Known CNS disease
- •Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women
- •Prior treatment within the last three weeks
- •Prior fludarabine
- •Positive direct antiglobulin test
研究组 & 干预措施
Fludarabine and Rituximab
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
干预措施: Fludarabine (Drug)
Fludarabine and Rituximab
Fludarabine:
25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles
Rituximab:
375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L
Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.
干预措施: Rituximab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Assessed after three- and six-cycles of therapy.
Objective response rate is defined as the proportion of patients who achieve complete remission (CR), complete remission/unconfirmed (CRu) or partial remission (PR) based on Cheson criteria (1999).
次要结局
- 3.1-Year Progression-Free Survival(Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years)
- 3.1-Year Overall Survival(Assessed after 3- and 6-cycles of therapy, every 6 months for 2 years and then annually up to 4 years)
研究者
Jennifer R. Brown, MD, PhD
Assistant Professor of Medicine
Dana-Farber Cancer Institute