NCT04506086终止4 期
A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 10
- 试验地点
- 12
- 主要终点
- Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP
研究概览
简要总结
The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures OR subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent
- •Age greater than or equal to 18 years
- •B-cell precursor (BCP) acute lymphoblastic leukemia (ALL) with minimal/measurable residual disease defined as hematologic complete remission (CR) with less than 5% bone marrow blasts and meets clinical eligibility criteria to receive blinatumomab as outlined below.
- •Hematologic criteria for remission as defined below:
- •Less than 5% bone marrow blasts
- •Absolute neutrophil count greater than or equal to 1.0 x10^9 L
- •Platelets greater than or equal to 50 x10^9/L (transfusion permitted)
- •Hemoglobin level greater than or equal to 90 g/L (transfusion permitted)
- •Renal and hepatic function as defined below:
- •Total bilirubin <3 x upper limit of normal (ULN) unless related to Gilbert's or Meulengracht disease
- •Serum creatinine <1.5 x ULN. If serum creatinine ≥1.5 x ULN, then measure Glomerular Filtration Rate (GFR); subject will be eligible only if measured GFR is within normal limits.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- •Negative pregnancy test in women of childbearing potential
- •Ability and willingness to wear and comply with the instructions for the use of and monitoring of the digital monitoring devices as outlined in informed consent
- •Subject resides within 1 hour of ground transportation to an advanced medical care facility for the duration of the mandatory device monitoring period (MDMP)
- •Adequate cellular service available during MDMP.
- •Presence of an adult (greater than or equal to 18 years) caregiver(s) in the same dwelling, for 24 hours/day for the entire MDMP. Caregiver will be expected to have access to transportation
- •Ability and willingness to participate in the health management of the subject and to assist with the requirements of remote digital monitoring devices during the blinatumomab infusion within the MDMP
排除标准
- •Presence of circulating blasts
- •Presence of extramedullary disease
- •History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or movement disorders
- •Current infiltration of cerebrospinal fluid (CSF) by ALL. If screening cerebrospinal fluid (CSF) demonstrates leukemic blasts, subjects must receive intrathecal treatment and demonstrate negative CSF before enrollment and starting blinatumomab infusion
- •Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- •Allogeneic hematopoietic stem cell transplantation (HSCT) within 12 weeks before blinatumomab treatment
- •Active acute or chronic graft versus host disease (GvHD) requiring systemic treatment with immunosuppressive medication
- •Systemic chemotherapy within 2 weeks prior to study treatment (except for intrathecal prophylaxis)
- •Radiotherapy within 4 weeks prior to study treatment
- •Known hypersensitivity to blinatumomab or to any component of the product formulation
- •Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- •History of other malignancy within the past 2 years, with the following exception[s]:
- •Malignancy treated with curative intent and with no known active disease present for greater than or equal to 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Adequately treated breast ductal carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
- •Currently receiving treatment with an investigational device or drug study or less than 30 days since ending treatment on an investigational device or drug study(ies)
- •Active uncontrolled infection requiring therapy
- •Known infection or chronic infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or hepatitis C virus (HCV) (anti-HCV positive)
- •Known positive test for human immunodeficiency virus (HIV)
- •Any concurrent disease or medical condition deemed to interfere with the conduct of the study and remote digital monitoring as judged by the investigator
- •Any acutely ill cardiac patients with the potential to develop life threatening arrhythmias eg, very fast atrial fibrillation
- •Subjects with no cellular signal in their home
- •Subjects with bi-lateral upper arm tattoos directly under the area of Current Wearable Health Monitoring System (CWHMS) application (Current Health wearable device)
- •Subjects with a known allergy to any of the device component materials
- •Subjects with open wounds on both arms directly under the area of CWHMS application (Current Health wearable device) or with injuries to both arms
- •Subjects with an upper arm circumference of less than 20 cm or greater than 50 cm
- •Subjects with an implantable defibrillator
- •Subjects unwilling to wear the CWHMS (Current Health wearable device, axillary temperature patch) during the mandatory monitoring period (MDMP) in cycles 1 and 2
- •Subjects with excessive scarring directly under the area of CWHMS (Current Health wearable device) application
- •Subjects who cannot have their blood pressure (BP) measured in both arms (or wrists) eg due to atrio-venous shunt, risk of lymphedema or peripherally inserted central catheter line
- •Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 48 hours after the last dose of protocol-specified therapy
- •Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 48 hours after the last dose of protocol-specified therapy Refer to Section 11.5 for additional contraceptive information
- •Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum pregnancy test and/or urine pregnancy test
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, patient reported outcomes [PROs]) to the best of the subject and investigator's knowledge
研究组 & 干预措施
Blinatumomab
Experimental
干预措施: Blinatumomab (Drug)
Blinatumomab
Experimental
干预措施: Current Wearable Heatlth Monitoring System (CWHMS) (Device)
结局指标
主要结局
Number of Participants With Grade 3 and/or 4 Cytokine Release Syndrome (CRS), Neurotoxicity (NT) or Any Adverse Events Resulting in Hospitalization During MDMP
时间窗: Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2
Adverse event were graded using the Common Terminology Criteria for Adverse Events, (CTCAE) v5.0 grading Scale. Grade 3 events were defined as severe or medically significant but not immediately life-threatening; grade 4 events were defined as life-threatening consequences; urgent intervention indicated. CSR is a heightened T-cell activation and release of pro inflammatory cytokines. NT signs include encephalopathy, delirium, aphasia, lethargy, difficulty concentrating, agitation, tremor, seizures, and, rarely, cerebral edema.
次要结局
- Time to Therapeutic Intervention (TTI) During MDMP(Cycle 1: Day 1 to Day 3; Cycle 2: Day 1 and Day 2)
- Number of Participants Who Experienced TEAEs That Resulted in Hospitalization, Surgeries, Use of Concomitant Medications or Use of Device/Procedure Intervention(Up to a maximum of 193 days)
- Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Adverse Events of Interest (EOIs)(Up to a maximum of 193 days)
- Change From Baseline to Cycle 2 Day 1 in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life of Cancer Patients (QLQ-C30) Global Health Status/ Quality of Life Score(Baseline and Cycle 2 Day 1)
研究者
研究点 (12)
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