Phase II Study of Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Overall Response Rate
研究概览
简要总结
Patients with post transplant lymphoproliferative disorder (PTLD) that have been treated with at least one type of chemotherapy, but whose lymphoma is not responding or coming back after the previous treatment will be asked to participate in this study.
This clinical trial uses a drug called Obinutuzumab. The Food and Drug Administration (FDA) has approved Obinutuzumab for sale in the United States for certain diseases. Obinutuzumab is still being studied in clinical trials to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied. Obinutuzumab is considered an investigational drug in this study
Obinutuzumab (GA101) is an antibody directed against cluster of differentiation antigen 20 (CD20). Antibodies are protein that are part of the immune system that can target cancer cells. Obinutuzumab sticks to a target called CD20. CD20 is an important molecule on some cancer cells (including non-Hodgkin lymphoma) and some normal cells of the immune system.
This study is being done to test if the study drug has an effect on post transplant lymphoproliferative disorder and to see how lymphoma will respond to the study drug.
详细描述
Primary Objective:
• To determine the overall response rate of obinutuzumab in relapsed/refractory post-transplant lymphoproliferative disorder (PTLD) in both solid organ transplant (SOT) and bone marrow transplant (BMT) patients
Secondary Objectives:
- Complete remission (CR) rate
- Duration of response (DOR)
- Progression free survival (PFS)
- Overall survival (OS)
- Time to treatment failure (TTF)
- Safety and tolerability of obinutuzumab
Patient Population:
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 or cytologically confirmed relapsed/refractory post-transplant lymphoproliferative disorder
- •Relapsed/refractory disease with at least 1 prior chemotherapy regimen
- •Measurable disease ≥1.5 cm
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •ECOG 3 will be permitted if the decline in the performance status is attributed to the lymphoma
- •Able to sign the consent form
- •Adequate organ function
- •bilirubin ≤1.5 times upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN or ≤5 times ULN for patients with document hepatic involvement with lymphoma
- •serum creatinine clearance >50 ml/min
- •absolute neutrophil count (ANC) ≥500/μL (unless documented bone marrow involvement with lymphoma)
- •hemoglobin >8 gm/dl
- •platelet count ≥50,000/μL (unless documented bone marrow involvement with lymphoma)
排除标准
- •Prior treatment with obinutuzumab
- •Pregnancy or breast feeding women
- •Current active malignancy other than PTLD, requiring active treatment
- •Presence of central nervous system (CNS) involvement
- •HIV positive patients
- •Myocardial infarction within the past 6 months
- •Patients with the following medical conditions that could affect their participation in the study:
- •any active acute or chronic or uncontrolled infection
- •liver disease including history of viral hepatitis B or C, evidence of cirrhosis, chronic active or persistent hepatitis
- •a known history of HIV
- •symptomatic cardiac disease, including congestive heart failure, coronary artery disease, and arrhythmias
- •Current therapy with chemotherapy or investigational agents within 4 weeks of start of study treatment
研究组 & 干预措施
Obinutuzumab
Patients will be treated with a total of 2 cycles of obinutuzumab.
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 36 months after beginning treatment
Overall response rate will be estimated by the total number of patients who achieve a CR and PR divided by the total number of evaluable patients. Response will be assessed using CT scans according to the revised Cheson criteria * CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy * PR is defined as at least 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses
次要结局
- Progression Free Survival(Up to 36 months after beginning treatment)
- Overall Survival(Up to 36 months after beginning treatment)
- Time to Treatment Failure(Up to 36 months after beginning treatment)
- Complete Response Rate(Up to 36 months after beginning treatment)
- Duration of Response(Up to 36 months after beginning treatment)