Safety and Feasibility Study of Chimeric Antigen Receptor (CAR) T Cell Therapy With YESCARTA in the Outpatient Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants That Received YESCARTA
研究概览
简要总结
We hope to demonstrate that YESCARTA can be safely administered in the outpatient setting if we closely monitor subjects with physical exams, wearable devices, and telemedicine visits and only admit those who meet specified criteria
详细描述
Primary Objectives
- To explore the feasibility of treating subjects with YESCARTA in the outpatient setting and guide the development of a subsequent, larger study that will determine the tolerability and safety profile of YESCARTA in the outpatient setting.
- To determine the time to specific interventions post infusion and the number of subjects who remain outpatient through 72 hours, 7, 14, and 30 days.
Secondary Objectives:
- Identify risk factors that preclude outpatient administration, and to obtain clinical data that will guide the development of guidelines by which YESCARTA treatment in the outpatient setting can be done safely.
- Assess the impact of close monitoring with telemedicine and twice-daily physical exam on specific outcomes including CRS and ICANS in subjects treated with YESCARTA in the outpatient setting.
- Cumulative steroid exposure within 28 days post YESCARTA infusion.
- To calculate the estimated cost of YESCARTA administered in the outpatient setting.
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- 未提供
排除标准
- •History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.
- •Known CD19 negative tumor.
- •History of Richter's transformation of chronic lymphocytic leukemia (CLL).
- •Autologous stem cell transplant with therapeutic intent within 6 weeks of planned YESCARTA infusion.
- •History of allogeneic stem cell transplantation.
- •Prior CAR therapy or other genetically modified T-cell therapy.
- •History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
- •Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor.
- •History of human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or hepatitis C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines or applicable country guidelines.
- •Presence of any in-dwelling line or drain (e.g., percutaneous nephrostomy tube, in-dwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.
- •Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases. Patients with treated secondary CNS involvement of lymphoma are allowed.
- •History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, progressive multifocal leukoencephalopathy, or any autoimmune disease with CNS involvement if it impairs ability to complete an effective and reliable neurological assessment.
- •Subjects with cardiac atrial or cardiac ventricular lymphoma involvement.
- •History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment.
- •Requirement for urgent therapy due to tumor mass effects (e.g., blood vessel compression, bowel obstruction, or transmural gastric involvement).
- •Primary immunodeficiency.
- •Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.
- •Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.
- •History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- •Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy.
- •In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- •History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- •Must not have received immunomodulating agents including checkpoint inhibitors, Bruton tyrosine kinase (BTK) inhibitors, and Revlimid within 2 months or 5 half-lives whichever is shorter.
研究组 & 干预措施
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Telemedicine Visit (Procedure)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Vital sign measurements (Procedure)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Out-Patient Clinic Visit (Procedure)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Blood pressure and pulse oximeter (Procedure)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Axicabtagene Ciloleucel (Biological)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Cyclophosphamide (Drug)
YESCARTA (Axicabtagene Ciloleucel) in the Outpatient Setting
Patients receive cyclophosphamide IV and fludarabine IV on days -5 to -3. Patients then receive YESCARTA IV for over 30 minutes on day 0 in the absence of disease progression of unacceptable toxicity.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Number of Participants That Received YESCARTA
时间窗: Approximately 6 weeks
The number of participants that received YESCARTA as outpatient therapy
Participants That Required Hospitalization at 72 Hours Post Infusion
时间窗: at 72 hours
Number of subjects that were admitted to hospital at 72 hours post infusion
Participants That Required Hospitalization at 7 Days Post Infusion
时间窗: at 7 days
Number of subjects that were admitted to the hospital at 7 days post infusion
Participants That Required Hospitalization at 14 Days Post Infusion
时间窗: at 14 days
Number of subjects that were admitted to the hospital at 14 days post infusion
Participants That Required Hospitalization at 30 Days Post Infusion
时间窗: at 30 days
Number of subjects that were admitted to hospital at 30 days post infusion
次要结局
- Count of Risk Factors That Preclude Out-patient Administration of YESCARTA(Approximately 30 days)
- Participants That Experienced Cytokine Release Syndrome Events(Approximately 30 days)
- Participants That Experienced Immune Effector Cell-associated Neurotoxicity Syndrome Events(Approximately 30 days)
- Incidence of Steroid Administration During YESCARTA(Approximately 30 days)
- Cost Per Patient of Administering YESCARTA in the Out-patient Setting(Approximately 30 days)
研究者
Olalekan Oluwole
Sponsor Investigator
Vanderbilt-Ingram Cancer Center