NCT04920968招募中2 期
Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia
Maria Sklodowska-Curie National Research Institute of Oncology19 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年10月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 19
- 主要终点
- Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
研究概览
简要总结
A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years.
- •Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.
- •Signed written informed consent.
- •Adequate contraception in case of women with child-bearing potential
排除标准
- •Lymphoblastic lymphoma with bone marrow blasts<20%.
- •Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.
- •Major surgery within 4 weeks before enrollment.
- •Impaired cardiac function: ejection fraction <40% on echocardiography, QTc interval > 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- •Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus
- •Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
- •Serum creatinine > 2 times the upper normal limit of the laboratory, total bilirubin> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase > 5 upper normal limit, unless related to Acute lymphoblastic leukemia
- •Intolerance to treatment with monoclonal antibody.
- •Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.
- •Inability to obtain written informed consent.
- •Inability to comply with regular monitoring.
研究组 & 干预措施
Obinutuzumab
Experimental
Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
干预措施: Obinutuzumab (Drug)
Rituximab
Active Comparator
Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.
干预措施: Rituximab (Drug)
结局指标
主要结局
Proportion of patients achieving complete remission with Minimal Residual Disease level <0.1% of bone marrow cells after one course of induction treatment.
时间窗: assessed between days 33-34 since start of Induction I
次要结局
- Probability of relapse-free survival(in 24 month follow up)
- Probability of event-free survival(in 24 month follow up)
- Cumulative incidence of relapse(in 24 month follow up)
- Rate of adverse events(in 24 month follow up)
- The proportion of patients achieving complete remission with Minimal Residual Disease level <0.01% of bone marrow cells after consolidation.(assessed between days 20-28 since start of last course of consolidation)
- complete remission rate after Induction I(assessed between days 33-34 since start of Induction I)
- Overall complete remission(in 24month follow up)
- Probability of overall survival(in 24 month follow up)
研究者
研究点 (19)
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