NCT00397800Unknown1 期
Safety and Efficacy of Sequential Treatment With a Combination of Rituximab, Fludarabine and Cyclophosphamide Followed by Zevalin (Rituximab and Y-Ibritumomab Tiuxetan) - A Phase I/II Study for Treatment of Patients With Relapsed Indolent and Transformed CD20-Positive B-Cell Non-Hodgkin's-Lymphoma Ineligible for High-Dose Chemo(Radio)Therapy Supported by Autologous Peripheral Blood Stem-Cells
Technical University of Munich24 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 24
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab and chemotherapy together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of yttrium Y 90 ibritumomab tiuxetan when given together with rituximab, fludarabine, and cyclophosphamide and to see how well they work in treating patients with relapsed B-cell non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of rituximab and yttrium Y 90 (^90Y) ibritumomab tiuxetan when administered with rituximab as radioimmunotherapy after rituximab, fludarabine, and cyclophosphamide in patients with relapsed indolent, mantle cell, or transformed CD20-positive B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the overall survival in patients treated with this regimen.
- Determine time to progression and event-free survival in patients treated with this regimen.
- Determine partial and complete response rates in patients treated with this regimen.
- Determine time to maximal response in patients treated with this regimen.
- Determine response duration in patients treated with this regimen.
- Determine the feasibility of additional antineoplastic treatment following disease relapse after treatment with rituximab and ^90Y ibritumomab tiuxetan in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed CD20-positive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
- •Indolent NHL, including any of the following:
- •Follicular
- •Lymphoplasmacytoid
- •Marginal zone
- •Mantle cell NHL
- •Transformed B-cell NHL
- •In at least first relapse with an indication for systemic antineoplastic treatment, as defined by the following:
- •Local or constitutional (B-) symptoms
- •Hypersplenism due to splenic involvement
- •Bulky disease (> 7.5 cm in diameter)
- •Impending medical problems derived from rapid disease progression within the past 6 months, as defined by an observed or anticipated > 50% increase in the sum of the areas calculated from multiplying the greatest perpendicular diameters of each lesion
- •Measurable lesions of lymphoma infiltration
- •Medically ineligible for high-dose treatment followed by autologous stem cell support
- •Adequate bone marrow cellularity (> 15% of marrow area covered by hematopoiesis)
- •No CNS, leptomeningeal, spinal cord, or testes lymphoma involvement
- •No lymphoma lesion mandating emergency radiotherapy
- •No clinical, cytological, cytogenetic, or histopathologic indication of myelodysplastic syndrome
- •If there is bone marrow infiltration detected prior to chemoimmunotherapy, patient must undergo a repeat bone marrow biopsy prior to planned treatment with radioimmunotherapy to verify the level of bone marrow infiltration is < 25%
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 150,000/mm³
- •Hemoglobin > 9 g/dL
- •Creatinine < 1.5 times upper limit of normal (ULN)
- •Bilirubin < 2 times ULN
- •ALT and AST < 2 times ULN
- •Albumin > 2.5 g/dL
- •INR < 1.5
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 12 months after completion of study treatment
- •No concurrent severe and/or uncontrolled medical disease that would preclude study compliance, including any of the following:
- •Uncontrolled diabetes
- •Congestive heart failure
- •Chronic renal disease
- •Active uncontrolled infection
- •No bleeding risks or disorders, including any of the following:
- •CNS abnormalities suggesting an increased susceptibility for hemorrhage, including recent history of stroke as demonstrated by cranial contrast-enhanced CT scan
- •Severe arrhythmia or uncontrolled hypertension
- •Myocardial infarction within the past 6 months
- •Diabetic retinopathy with history of symptomatic hemorrhage
- •Known and potentially active gastrointestinal bleeding foci
- •Concurrent anticoagulant medication that must be continued even with platelet count < 20,000/mm³ (e.g., following mitral valve replacement, anti-phospholipid syndrome, or recurrent venous thromboembolism)
- •Other congenital or acquired hemorrhagic diatheses
- •No ongoing autoimmune hemolytic anemia
- •No known presence of anti-murine antibody reactivity
- •No known hypersensitivity to murine or chimeric antibodies or proteins
- 另有 15 项未显示
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity
次要结局
- Response
- Survival
研究者
研究点 (24)
Loading locations...
相似试验
已完成
2 期
Phase 2 Study of Rituximab-ABVD in Classical Hodgkin LymphomaLymphomaNCT00369681Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins51
已完成
1 期
Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's LymphomaLymphomaNCT00244985Roswell Park Cancer Institute42
已完成
3 期
Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's LymphomaLymphomaNCT00112931University College, London462
已完成
3 期
Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT00275054German CLL Study Group825
撤回
2 期
Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell LymphomaLymphomaNCT00983944Ohio State University Comprehensive Cancer Center