HM2014-26 DT2219 Immunotoxin for the Treatment of Relapsed or Refractory CD19 (+) and/or CD 22 (+) B-lineage Leukemia or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
研究概览
简要总结
This is a phase I/II study of DT2219 for the treatment of relapsed or refractory CD19 (+) and/or CD 22 (+) B-lineage leukemia and lymphoma. The study consists of two phases - a phase I dose/schedule finding component using the maximum tolerated dose identified during the previous phase I study, but with a higher number of doses and a two-stage phase II extension component to confirm safety and make a preliminary determination of the activity level by disease using the dose identified in phase I.
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
- •Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
- •Relapsed refractory disease that has failed conventional therapy and other therapies of higher priority
- •Karnofsky Performance status of ≥ 60% or, if less than 16 years of age, Lansky Play Score of ≥ 60 (appendix II)
- •Recovered from effects of prior therapy
- •Peripheral blast count under 50 x 10^9/L
- •Adequate organ function within 14 days (30 days for cardiac and pulmonary) of treatment start
- •Women of childbearing potential and men should be advised and agree to practice effective methods of contraception during the course of study
- •Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
排除标准
- •Presence of leukemic or infectious pulmonary parenchymal disease
- •Presence of active CNS leukemia
- •Presence of any uncontrolled systemic infection
- •Documented uncontrolled seizure disorder- a seizure disorder controlled with medication
- •Active neurologic disorder - peripheral neuropathy alone does not exclude a patient
- •Active Hepatitis B or Hepatitis C (virus detectable by PCR)
- •Documented penicillin or cephalosporin allergies
- •Pregnant or lactating
结局指标
主要结局
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
时间窗: Day 1 - Day 29
Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
Phase ll: Overall Disease Response
时间窗: Day 29
Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.
次要结局
- Incidence of Serious Adverse Events(Day 29)
- Disease-free Survival(1 year)
- Overall Survival(1 year)
- Time to Relapse/Progression(1 year)
- Phase II : Duration of Response(1 year)