NCT00618696终止1 期
MT2005-13R - Phase I Open Label, Single Arm, Dose Escalation Trial to Evaluate the Biodistribution and Safety of AHN-12 in Patients With Advanced Leukemia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12
研究概览
简要总结
RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.
详细描述
OBJECTIVES:
Primary
- To establish that a dose of 150 mg/m² of nonradiolabeled anti-CD45 monoclonal antibody AHN-12 results in normal biodistribution, normal-organ estimated radiation-absorbed dose of less than 20 Gy, and estimated radiation-absorbed dose of no more than 13 Gy to the red marrow.
Secondary
- To determine the maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (^90Y-AHN-12).
- To determine the human anti-mouse antibody (HAMA) response.
- To define, preliminarily, the antitumor activity of ^90Y-AHN-12.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed CD45+ diseases:
- •Acute lymphoblastic leukemia or acute myeloid leukemia (AML), meeting any of the following criteria:
- •Primary refractory disease
- •Relapsed disease, defined as persistent disease following a minimum of 2 different standard chemotherapy induction attempts at time of diagnosis or at relapse
- •Acute myelogenous leukemia (AML), primary refractory or relapsed disease - defined as persistent disease after a minimum of two different standard chemotherapy induction attempts at time of diagnosis or relapse
- •Advanced myelodysplastic syndrome (MDS) defined as > or = 15% bone marrow blasts following a minimum of one standard chemotherapy induction attempt
- •AML arising from preexisting MDS, refractory - defined as persistent disease following a minimum of one standard chemotherapy induction attempt
- •Chronic myelogenous leukemia (CML) following blast crisis (> or = 15% marrow blasts following a minimum of one standard chemotherapy induction attempt
- •Peripheral leukemic blasts (by morphology) must be < 5,000/μL (hydroxyurea to control peripheral blast count allowed)
- •Must have source of allogeneic stem cells (sibling, unrelated cord[s], or donor) identified prior to initiation of protocol therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •Total bilirubin ≤ 2.5 times upper limit of normal (ULN)
- •aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.3 mg/dL OR creatinine clearance ≥ 60 mL/min
- •Left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO)
- •Carbon Monoxide Diffusing Capacity (DLCO) (corrected) ≥ 50% of predicted
- •Human anti-mouse antibody (HAMA) must be negative
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •Human immunodeficiency virus (HIV) negative
- •Recovered from all prior therapy
- •At least 7 days since prior biologic agents
排除标准
- •Bone marrow cellularity < 15%
- •Known brain metastases or active central nervous system (CNS) disease
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to ^90Y-AHN-12 or other agents used in study
- •Uncontrolled illness, including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic or congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would limit compliance with study requirements
- •Other concurrent investigational agents
- •Prior allogeneic transplantation
- •Less than 60 days since prior autologous transplantation with relapsed disease
研究组 & 干预措施
AHN-12
Experimental
2.0, 5.0, 7.5, 10.0 or 12.5 mCi/m^2 of ^90Y-AHN-12 at Day 7/8
干预措施: anti-CD45 monoclonal antibody AHN-12 (Biological)
AHN-12
Experimental
2.0, 5.0, 7.5, 10.0 or 12.5 mCi/m^2 of ^90Y-AHN-12 at Day 7/8
干预措施: yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (Radiation)
结局指标
主要结局
Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12
时间窗: Within 1 hour, 4-6 hours, Days 1, 3, 4 and 7 post infusion
次要结局
- Presence of human antibody to murine antibody(at baseline and at 28 days, 90 days, and 6 months after completion of study treatment)
- Dose-limiting toxicity and response(at days 28 and 90 after completion of study treatment)
- Maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12(Week 8)
研究者
研究点 (1)
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