NCT00276159终止2 期
Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
研究概览
简要总结
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
详细描述
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.
- •acute lymphoblastic leukemia (ALL)
- •acute myeloid leukemia (AML)
- •non-Hodgkin's lymphoma (NHL)
- •Hodgkin's lymphoma (HL)
- •multiple myeloma (MM)
- •chronic lymphocytic leukemia (CLL)
- •Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age
- •Normal organ function within 14 days of study entry
- •If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
排除标准
- •Had/have the following prior/concurrent therapy:
- •Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)
- •Investigational drugs/agents within 14 days of first dose of 852A
- •Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)
- •Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions
- •Radiotherapy within 4 weeks of the first dose of 852A
- •Hematopoietic cell transplantation 4 weeks of first dose of 852A
- •Active infection or fever > 38.5°C within 3 days of first dose of 852A
- •Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication
- •History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
- •Uncontrolled intercurrent or chronic illness
- •Active autoimmune disease requiring immunosuppressive therapy within 30 days
- •Active hepatitis B or C with evidence of ongoing viral replication
- •Hyperthyroidism
- •Uncontrolled seizure disorder
- •Active coagulation disorder not controlled with medication
- •Pregnant or lactating
- •Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated
- •Proven active central nervous system (CNS) disease
- •Human Immunodeficiency Virus (HIV) positive
- •Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and > 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).
研究组 & 干预措施
852A Treatment
Experimental
Patients receiving at least one dose of 852A.
干预措施: 852A (Drug)
结局指标
主要结局
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
时间窗: Up to Week 12
Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.
次要结局
- Number of Patients Who Received Steroids(Up to Week 12)
- Measure of Immune Activation With Correlative Laboratory Studies(Up to Week 12)
- Peak Concentrations of 852A(Up to Week 12)
研究者
研究点 (1)
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