Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With Toxicities
研究概览
简要总结
You are being asked to take part in this study because you either had Ph positive B-lineage acute lymphoblastic leukemia (ALL) or still have a small amount of the disease and recently received an allogeneic stem cell transplant (cells from someone else).
The goal of this clinical research study is to learn if blinatumomab in patients who have had an allogeneic stem cell transplant can help to control ALL or prevent ALL from coming back in patients who either have a small amount of ALL or have had ALL in the past. The safety of this drug will also be studied.
详细描述
Study Drug Administration:
Every study cycle will be 6 weeks. You may receive up to 4 cycles of blinatumomab. Each cycle will start around 3, 6, 9, and 12 months after your stem cell transplant.
In each cycle, you will receive blinatumomab as a continuous infusion by vein for 4 weeks, followed by a 2 week "rest period" during which you will not receive blinatumomab.
You will need to remain in the hospital for the first 2 cycles so that you can be checked on for side effects.
Length of Study:
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
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 1-70 years of age.
- •Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at time of transplant; patients beyond CR1 or with primary induction failure may be without minimal residual disease, b) any residual disease defined by positive flow >0.01%, detection of BCR-ABL transcript by PCR with a sensitivity of 1/10,000, or detection of the t(9;22) translocation in any metaphases by cytogenetics at time of transplant, or presence of the MLL gene.
- •Received an allogeneic HCT within the last 100 days. Enrollment within 30-100 days after transplant, and after adequate recovery of counts defined as ANC >/= 0.5 x 10^9/L without daily use of myeloid growth factor and platelet > 20 x 10^9/L without platelet transfusion within 1 week, and adequate organ function to receive blinatumomab defined as creatinine clearance greater than 30 ml/min, ALT/AST < 5 x ULN and serum bilirubin < 3 x ULN.
- •Performance status of 0, 1, or
- •Karnofsky (or Lansky for subjects < 16 years old) performance status >/= 50.
排除标准
- •Relapsed ALL defined as >5% malignant blasts in bone marrow or peripheral blood.
- •Active GVHD requiring systemic steroid therapy. Medications for GVHD prophylaxis are acceptable.
- •Systemic steroid therapy unless for physiologic replacement
- •Uncontrolled disease/infection as judged by the treating physician
- •Active ALL in the central nervous system (CNS), as defined by >/= 5 leukocytes per microL with identifiable blast cells in the CSF, and/or the presence of cranial-nerve palsies
- •Pregnant or nursing women
研究组 & 干预措施
Blinatumomab
Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).
干预措施: Blinatumomab (Drug)
Blinatumomab
Blinatumomab as continuous intravenous infusion at dose of 28 µg/24 hours over 4 weeks followed by 2 week treatment-free period for 6-week treatment cycle; 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).
干预措施: Hematopoietic Cell Transplantation (Procedure)
结局指标
主要结局
Number of Participants With Toxicities
时间窗: 30 days from the first cycle
Participants with treatment-related toxicities attributable to Blinatumomab. Toxicities defined as any 1) grade 3-4 acute GVHD greater than 30%, 2) secondary graft failure \>30%, or 3) nonrelapse mortality (NRM) within one cycle of Blinatumomab.
次要结局
- Progression Free Survival (PFS)(From last treatment cycle, assessed up to 1 year)
- Overall Survival (OS)(From last treatment cycle, assessed up to 1 year)