2024-517389-40-00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
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy19 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年10月7日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 19
- 主要终点
- The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
研究概览
简要总结
To compare efficacy of obinutuzumab and rituximab in adult patients with newly diagnosed CD20-positive ALL. The efficacy for this purpose is defined as the proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years.
- •Newly diagnosed ALL 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%.
- •Inability to obtain written informed consent
- •Inability to comply with regular monitoring.
- •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 ECG. 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. HBV, HCV, HIV
- •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 (UNL) of the laboratory, total bilirubin> 2.5 UNL unless related to ALL, AST or ALT >5 UNL, unless related to ALL
- •Intolerance to treatment with monoclonal antibody.
- •Positive pregnancy test (β-HCG) for women of childbearing age
结局指标
主要结局
The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
The proportion of patients achieving complete remission (CR) with MRD level <0.1% of bone marrow cells after one course of induction treatment
次要结局
- The proportion of patients achieving CR with MRD level <0.01% of bone marrow cells after consolidation.
- CR rate after Induction I.
- Overall CR rate in 24 month follow-up.
- Probability of overall survival (OS) in 24 month follow-up
- Probability of relapse-free survival (RFS) in 24 month follow-up
- Probability of event-free survival (EFS) in 24 month follow-up
- Cumulative incidence of relapse in 24 month follow-up
- Rate of adverse events in 24 month follow-up.
研究者
Clinical Research Support Center
Scientific
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
研究点 (19)
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