NCT05456698进行中（未招募）2 期
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy: A Phase 2, Open-label, Single-arm, Single-center Trial
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年10月18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
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- MRD negativity rate within the first treatment cycle
研究概览
简要总结
A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
- •Age ≥18 years
- •ECOG PS score: 0 to 2
- •Functions of the main organs are normal, if the following criteria are met:
- •Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
- •Serum creatinine ≤ 1.5 × ULN
- •Creatinine clearance ≥ 30 ml/min
- •No active or co-existing malignancy with a life expectancy of less than 12 months
- •Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.
排除标准
- •Mixed lineage leukemia
- •Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
- •Patients with severe and / or uncontrolled diseases, such as:
- •Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- •Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
- •Known to be human immunodeficiency virus positive (HIV+)
- •Active and uncontrolled disease/infection as judged by the treating physician
- •Active central nervous system (CNS) or extramedullary disease
- •Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
- •Pregnant or nursing women
- •Unable or unwilling to sign the consent form
- •Monoclonal antibodies therapy within 2 weeks before study entry
- •Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
- •Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
- •Patients in other situations who are evaluated by the investigator to be ineligible
研究组 & 干预措施
Inotuzumab Ozogamicin
Experimental
Each subject will be treated with Inotuzumab Ozogamicin
干预措施: Inotuzumab ozogamicin (Drug)
结局指标
主要结局
MRD negativity rate within the first treatment cycle
时间窗: At the end of Cycle 1 (each cycle is 28 days)
MRD negativity is defined as no presence of small numbers of leukemic cells detected by the flow cytometry after remission
次要结局
- Complete MRD response rates(At the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days))
- Overall Survival (OS)(Up to 5 years from enrollment)
- Duration of MRD negativity rate(From enrollment to the end of Cycle 1 or Cycle 2, which achieves MRD negative first (each cycle is 28 days))
- MRD level variation from baseline to post cycle 1, cycle 2 in patients with detectable MRD, respectively(From enrollment to the end of Cycle 1 and Cycle 2, respectively (each cycle is 28 days))
- Relapse-free Survival (RFS)(Up to 5 years from enrollment)
研究者
研究点 (1)
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