NCT00313053终止1 期
A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia
Clare Twist1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Maximum tolerable dose without toxicity
研究概览
简要总结
This is a phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent and with vincristine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be > than 12 months at the time of study entry.
- •Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.
- •For patients WITHOUT prior allogeneic bone marrow transplant (BMT):
- •Second or subsequent bone marrow relapse
- •Primary refractory marrow disease
- •M3 marrow (> 25% blasts)
- •For patients WITH prior allogeneic BMT:
- •First or subsequent bone marrow relapse post-BMT
- •M3 marrow or M2 (> 5% and < 25% blasts) if cytogenetic or variable number tandem repeat (VNTR) confirmation
- •Confirmation of antibody reactivity
- •Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab).
- •Patient's red blood cell (RBC) documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab)
- •Patient must not be eligible for therapies of higher priority
- •Performance level Karnofsky 50% for patients > 10 years of age and Lansky >= 50 for patients <= 10 years of age.
- •Life expectancy must be at least 8 weeks.
- •Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study:
- •Myelosuppressive chemotherapy: must not have been received within 2 weeks of entry onto this study.
- •Biologic: at least 7 days since the completion of therapy with a biologic agent.
- •No hematologic criteria for white blood cell (WBC), hemoglobin (Hgb), or platelets
- •Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.
- •Adequate renal function defined as: a serum creatinine that is less than or equal to 1.5 x normal for age
- •Adequate liver function defined as: total bilirubin <= 1.5 x upper limit of normal (ULN) for age, and SGPT (ALT) <= 5 x upper limit of normal (ULN) for age
- •Adequate cardiac function defined as: shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study.
- •All patients and/or their parents or legal guardians must sign a written informed consent/assent.
- •All Institutional Review Board (IRB) and Food and Drug Administration (FDA) requirements for human studies must be met.
排除标准
- •Central nervous system (CNS) 3 or refractory CNS leukemia
- •Isolated extramedullary relapse
- •Uncontrolled infection
- •Lack of mAb 216 binding to patient's leukemic blasts in vitro
- •Binding of mAb 216 to the"i" antigen on patient's erythrocytes
- •Prior treatment with rituximab
研究组 & 干预措施
Human mAb 216
Experimental
干预措施: Human mAb 216 (Drug)
Human mAb 216
Experimental
干预措施: Vincristine (Drug)
结局指标
主要结局
Maximum tolerable dose without toxicity
Safety
次要结局
- Decrease in leukemic blasts
研究者
Clare Twist
Associate Professor of Pediatrics
Stanford University
研究点 (1)
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