NCT03610438进行中（未招募）2 期
A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients With B-Cell Acute Lymphoblastic Leukemia With Positive Minimal Residual Disease Before Any Hematopoietic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 59
- 主要终点
- Number of patients obtaining a negative Minimal Residual Disease (MRD)
研究概览
简要总结
This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation.
The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ph+ ALL with p190 or p210 detectable and measurable (at least 10-4 x10000 ABL) after at least 3 months of any therapy, or the failure of at least 2 TKI.
- •Ph- ALL with detectable and measurable IG specific transcript after at least 2 courses of previous therapy.
- •Age ≥ 18 years old.
- •ECOG ≤ 2.
排除标准
- •More than 5% of BM blasts.
- •WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).
- •Active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN.
- •Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography.
- •History of alcohol abuse.
- •Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well co-morbidity will be carefully evaluated for enrolment.
- •Ongoing or active infections.
- •Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL). Clinically significant, uncontrolled, or active cardiovascular disease.
- •Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
- •Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day.
- •Documented inherited protrombotic disorders
- •Patients who have received any investigational drug ≤ 4 weeks.
- •Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- •Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy <6 months.
- •Patients that have received Inotuzumab or Anti CD22 directed therapies before
- •Patients with known hereditary coagulopathy
- •Patient that received during their life diagnosis of VOD or had ongoing VOD
- •Patients who are pregnant or breastfeeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs.
- •Patients unwilling or unable to comply with the protocol.
结局指标
主要结局
Number of patients obtaining a negative Minimal Residual Disease (MRD)
时间窗: Two years after study entry.
Primary end point is % of MRD negativity after course 2 (or course 1 if will be performed only course1).
Primary end point is % of MRD negativity after course 2 (or course 1 if will be performed only course1).
次要结局
- Number of patients alive(Two years from start of treatment.)
- Number of adverse events in MRD positive patients(Two years after study entry.)
- Molecular Disease Progression: defined as the rise of more than 2 log in MRD from any previous determination
- Disease Progression: this is also equivalent to Treatment Failure, Lack of Efficacy, or No Response.
- Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause or lost to follow up.
- Event Free Survival (EFS), defined as the number of days between the first study drug administration and any event including disease progressionor death.
- DFS (Disease Free Survival), defined as the interval between the date of response achievement and the date of death, relapse or last follow-up.
- Incidence time and nature of any adverse event.
- Severe effect related to treatment safety is defined as an adverse event occurring within the first cycle, judged to be related to treatment and meeting any of the following criteria: o Grade 3 non-hematological toxicity lasting more than 7 days. o Grade 4 non-hematological toxicity.
- Incidence, severity, seriousness and treatment-causality of Treatment Emergent Signs and Symptoms.
- Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12-Lead ECG.
- VOD occurred during or after protocol or transplant procedures for up to 2 years.
研究者
CENTRO DATI
Scientific
Fondazione Gimema Franco Mandelli Onlus
研究点 (59)
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