Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants to Achieve Complete Remission (CR)
研究概览
简要总结
This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet recovery [CRp] + CR with incomplete bone marrow recovery [CRi]) in patients in first, second or later salvage setting.
SECONDARY OBJECTIVES:
I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1), progression free survival (PFS), and overall survival (OS).
OUTLINE:
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 12 years of age
- •Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on local immunophenotyping and histopathology who have:
- •Refractory disease, defined as disease progression or no response while receiving their most recent prior anti-cancer therapy,
- •Relapsed disease, defined as response to their most recent prior anti-cancer therapy with subsequent relapse
- •Performance status of 0 to 3
- •Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >= 15 mL/min as calculated using the method standard for the institution
- •Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome. If organ function abnormalities are considered due to tumor, total serum bilirubin must be =< 2 x ULN
- •Aspartate and alanine aminotransferase (AST or ALT) =< 2.5 x ULN
- •No active or co-existing malignancy requiring chemotherapy or radiation within 6 months
- •Female subjects of childbearing potential should be willing to use effective methods birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. Effective methods of birth control include birth control pills or injections, intrauterine devices (IUDs), or double-barrier methods (for example, a condom in combination with spermicide)
- •Male subjects should agree to use an effective method of contraception starting with the first dose of study therapy through the duration of treatment
排除标准
- •Pregnant or nursing women
- •Known to be human immunodeficiency virus (HIV)+
- •Philadelphia chromosome (Ph)+ ALL
- •Active and uncontrolled disease/infection as judged by the treating physician
- •Unable or unwilling to sign the consent form
- •Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy within =< 4 months before first dose of study treatment
- •Active central nervous system (CNS) or extramedullary disease unless approved by the principal investigator (PI)
- •Monoclonal antibodies therapy within 2 weeks before study entry
- •Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy, hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used emergently in case of leukocytosis) or any investigational drug within 2 weeks before study entry
- •Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
结局指标
主要结局
Number of Participants to Achieve Complete Remission (CR)
时间窗: Up to 2 years
Complete Remission (CR) is the normalization of the peripheral blood and bone marrow with \</= 5% blasts with a granulocyte count of 1X10\^9/L or above and a platelet count of \>/= 100X10\^9/L and absence of extramedullary disease.
次要结局
- Overall Survival(Up to 3 years)
- Duration of Response(Up to 3 years)
- Participants With a Grade 3 or 4 Non-hematologic Adverse Event (AE)(Up to 2 years)
- Progression Free Survival(Up to 3 years)