Phase II Trial of Bortezomib and Rituximab for Patients With Post Transplant Lymphoproliferative Disorders (PTLD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Patients With Overall (Complete and Partial) Response Rates
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Monoclonal antibodies, such as rituximab, can block cancer cell 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. Giving bortezomib together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with post-transplant lymphoproliferative disorders.
详细描述
OBJECTIVES:
Primary
- To estimate the overall (complete and partial) response rates in patients with CD20+ post-transplant lymphoproliferative disorders treated with bortezomib and rituximab.
Secondary
- To evaluate the duration of remission, time to treatment failure, relapse-free survival, and overall survival of these patients.
- To characterize the quantitative and qualitative toxicities of this regimen.
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 CD20+ B-cell post-transplant lymphoproliferative disorder
- •Has undergone prior solid organ transplant
- •Measurable disease as defined by Non-Hodgkin Lymphoma Response Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Absolute neutrophil count (ANC) ≥ 1,000/mm³
- •Platelet count ≥ 75,000/mm³
- •Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
- •Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times upper limit of normal
- •Total bilirubin ≤ 2.0 mg/dL
排除标准
- •Pregnant or nursing
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •Peripheral neuropathy ≥ grade 2
- •Known lymphomatous meningitis or central nervous system (CNS) involvement
- •HIV infection
- •Uncontrolled infection
- •Myocardial infarction within the past 6 months or uncontrolled angina
- •New York Heart Association class III-IV heart failure
- •Severe uncontrolled ventricular arrhythmias
- •Evidence of acute ischemia or active conduction system abnormalities by electrocardiogram (EKG)
- •Concurrent serious medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- •Diagnosis or treatment for another malignancy within the past 3 years, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
- •Known hypersensitivity to rituximab, bortezomib, boron, or any of the other agents used in this study
- •Less than 14 days since prior investigational drugs
- •Less than 4 weeks since prior bortezomib therapy (12 weeks for rituximab) and recovered from toxic effects prior to enrollment
研究组 & 干预措施
Treated Patients
This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).
干预措施: rituximab (Biological)
Treated Patients
This group includes patients receiving Bortezomib and Rituximab for post-transplant lymphoproliferative disorders (PTLD).
干预措施: bortezomib (Drug)
结局指标
主要结局
Number of Patients With Overall (Complete and Partial) Response Rates
时间窗: Day 1 to 2 Years Post Treatment
次要结局
- Relapse-free Survival(at 2 years)
- Overall Survival(at 2 years)
- Time to Treatment Failure(Day 1 to Time of Disease Progression)
- Remission Duration Among Patients Who Respond to Treatment(Day 1 to 8 Months Post Treatment)