Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 545
- 试验地点
- 483
- 主要终点
- Time to Rituximab Failure (TTRF)
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms.
Secondary
- To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms.
- To document the rationale for beginning cytotoxic therapy; defined as chemotherapy, radiation therapy or radioimmunotherapy.
- To compare the toxicities associated with rituximab therapy between the two randomized treatment arms.
- Quality of Life Objectives:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:
- •Follicular grade 1 or 2
- •Small lymphocytic
- •Marginal zone (nodal)
- •Marginal zone (splenic)
- •Mucosa-associated lymphoid tissue (MALT)
- •Stage III or IV disease
- •Must meet the following criteria for low tumor burden:
- •No nodal or extranodal mass at least 7 cm
- •Less than 3 nodal masses greater than 3 cm in diameter
- •No systemic symptoms or B symptoms
- •No splenomegaly greater than 16 cm by a computed tomography (CT) scan
- •No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)
- •No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes
- •No cytopenias, defined as any of the following:
- •Platelet count less than 100,000/mm^3
- •Hemoglobin less than 10 g/dL
- •Absolute neutrophil count less than 1,500/mm^3
- •At least 1 objective measurable disease parameter
- •Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging
- •Age: 18 and over
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Must meet the following criteria for labs:
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3*
- •Hemoglobin at least 10 g/dL*
- •Platelet count at least 100,000/mm^3*
- •NOTE: *Without growth factor and/or transfusion support
- •Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin normal for patients with Gilbert's Syndrome
- •The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN
- •Hepatitis B surface antigen negative
- •Creatinine no greater than 2 times ULN
排除标准
- •Evidence of transformation to a large cell histology
- •Pregnant or nursing. Fertile patients must use effective contraception
- •HIV positive
- •Uncontrolled active infection
- •Other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Prior immunotherapy for lymphoma
- •Prior chemotherapy for lymphoma
- •Concurrent chemotherapy
- •Prior radiotherapy for lymphoma
- •Concurrent radiotherapy
- •Concurrent radioimmunotherapy
研究组 & 干预措施
Arm B: Rituximab Scheduled
Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
干预措施: rituximab (Biological)
Arm A: Rituximab Retreatment
Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
干预措施: rituximab (Biological)
结局指标
主要结局
Time to Rituximab Failure (TTRF)
时间窗: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.
TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
次要结局
- Time to First Cytotoxic Therapy (TTFC)(Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.)
- Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization(Assessed at baseline and 6 months after randomization.)