NCT00313079已完成1 期
A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Adult Patients With Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia
Steven E. Coutre2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
研究概览
简要总结
A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. Trial will study 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
- 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
- •3.1.1 Age Patients must be >= 18 years old at the time of study entry.
- •3.1.2 Diagnosis
- •3.1.2.1 Histologic Verification Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.
- •3.1.2.2 For patients WITHOUT prior allogeneic BMT:
- •Second or subsequent bone marrow relapse
- •Primary refractory marrow disease
- •M3 marrow (>25% blasts) or >25% leukemic blasts in peripheral blood
- •3.1.2.3 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 VNTR confirmation
- •3.1.3 Confirmation of antibody reactivity 3.1.3.1 Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab) 3.1.3.2 Patient's RBC documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab)
- •3.1.4 Patient Must Not Be Eligible For Therapies of Higher Priority
- •3.1.5 Performance Level (See Appendix I) Karnofsky >= 50%
- •3.1.6 Life Expectancy Must be at least 8 weeks.
- •3.1.7 Prior Therapy 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 received within one week of entry onto this study.
- •Biologic, including monoclonal antibodies: At least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
- •Hydroxyurea can be used up to 72 hours before study entry
- •3.1.8 Organ Function Requirements
- •3.1.8.1 Bone Marrow Function: 3.1.8.1.1 No hematologic criteria for WBC, Hgb or platelets 3.1.8.1.2 Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.
- •3.1.8.2 Adequate Renal Function Defined As:
- •- A serum creatinine that is less than or equal to 2 x normal for age
- •3.1.8.3 Adequate Liver Function Defined As:
- •Total bilirubin <= 2 x upper limit of normal (ULN) for age, and
- •SGPT (ALT) <= 5 x upper limit of normal (ULN) for age
- •3.1.8.4 Adequate Cardiac Function Defined As:
- •Shortening fraction of >= 27% by echocardiogram, or
- •Ejection fraction of >= 50% by gated radionuclide study.
- •3.1.9 Regulatory
- •3.1.9.1 All patients must sign a written informed consent. 3.1.9.2 All institutional (IRB) and FDA requirements for human studies must be met.
排除标准
- •3.2.1 CNS 3 or refractory CNS leukemia
- •3.2.2 Isolated extramedullary relapse
- •3.2.3 Uncontrolled infection
- •3.2.4 Lack of mAb 216 binding to patient's leukemic blasts in vitro
- •3.2.5 Binding of mAb 216 to the "i" antigen on patient's erythrocytes
结局指标
主要结局
In this phase I study the endpoint is the determination of the maximum tolerable dose without toxicity.
次要结局
- A decrease in leukemic blasts. The study will be terminated if unacceptable doseSecondary endpoints are a decrease in leukemic blasts. The study will be terminated if unacceptable dose limiting toxicity is found. This is a phase I trial to study safety.
研究者
Steven E. Coutre
Associate Professor of Medicine
Stanford University
研究点 (2)
Loading locations...
相似试验
终止
1 期
Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic LeukemiaLeukemia, Lymphocytic, AcuteAcute Lymphoid Leukemia (ALL)LeukemiaNCT00313053Clare Twist4
已完成
1 期
A Study Of Panobinostat In Children With Refractory Hematologic MalignanciesLymphoblastic Leukemia, Acute, ChildhoodMyelogenous Leukemia, Acute, ChildhoodHodgkin's DiseaseNon-Hodgkin's LymphomaNCT01321346Therapeutic Advances in Childhood Leukemia Consortium30
已完成
2 期
Avelumab With Chemoradiation in Locally Advanced Rectal CancerRectal CancerNCT03299660Peter MacCallum Cancer Centre, Australia37
已完成
1 期
Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult ParticipantsHIV InfectionsNCT03735849National Institute of Allergy and Infectious Diseases (NIAID)28
已完成
1 期
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's LymphomaLymphomaNCT00004101National Cancer Institute (NCI)35