NCT06427330招募中2 期
Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年7月2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
- 21
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.
详细描述
This is a Phase II study of inotuzumab ozogamicin for the treatment of patients who underwent transplantation for ALL and have a high risk of relapse. Participants will receive study treatment two doses until relapse of disease, unacceptable toxicity, or death, whichever occurs first Primary Objective
• To assess the efficacy of inotuzumab ozogamicin as measured by disease free survival (DFS) at one year.
Secondary Objective(s)
- To evaluate relapse rate, nonrelapse mortality (NRM), relapse, relapse-related mortality and overall survival (OS) at 1 year.
- To determine safety profile of inotuzumab ozogamicin after transplant including the incidence of hematological toxicity, secondary graft failure and other adverse event(AE)/severe adverse event(SAEs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
- •Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia
- •Patients who are after T+60 after transplantation
- •Patients who have/are either:
- •High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic
- •Relapsed or refractory to at least 1 line of treatment
- •Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test
- •Patients who have > 99% donor chimerism after allogeneic transplantation.
- •Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2
- •Participants must have ANC > 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count > 50,000/µL for 7 days.
- •≥ 18 years old, including male and female
- •Participants must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with evidence of disease progression prior to enrollment
- •Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
- •Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:
- •Severe renal deficiency, with creatinine clearance < 50ml/min
- •Severe hepatic deficiency
- •Bilirubin, aspartate aminotransferase(AST), and/or ALT(ALT) > 2X institutional upper limit of normal
- •Severe cardiac or pulmonary deficiency
- •Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).
- •Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)
- •History of veno-occlusive disease(VOD)
- •Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)
- •Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- •Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
研究组 & 干预措施
Inotuzumab ozogamicin
Experimental
干预措施: Inotuzumab ozogamicin (Drug)
结局指标
主要结局
DFS
时间窗: at one year after HSCT
Efficacy as measured by DFS at one year, estimated using Kaplan-Meier, reported as median and 2-sided 80% and 95% Confidence Interval (CI) DFS is defined as "Time from date of HSCT to the date of disease progression (ie,objective progression, relapse from CR/CRi), or death due to any cause, whichever occurs first (including post-study treatment follow-up disease assessments)".
次要结局
- NRM(at one year after HSCT)
- Percent of participants with AE/SAEs(at one year after HSCT)
- Overall survival(at one year after HSCT)
- Relapse(at one year after HSCT)
- Incidence of hematological toxicity(at one year after HSCT)
- Incidence of secondary graft failure(GF)(at one year after HSCT)
研究者
研究点 (1)
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