Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Occurrence of CRS
研究概览
简要总结
This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma
- •Adequate bone marrow function to receive lymphodepleting chemotherapy
- •Renal function </= 60mL/min/1.73m2
排除标准
- •Relative CNS disorders
- •Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
- •Use of therapeutic dose systemic corticosteroids (defined as >20mg/day prednisone or equivalent) within 72 hours of CAR-T administration
研究组 & 干预措施
Dialysis Participants
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
干预措施: Fludarabine (Drug)
Dialysis Participants
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
Moderate Renal Dysfunction
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
干预措施: Fludarabine (Drug)
Severe Renal Dysfunction
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
干预措施: Fludarabine (Drug)
Severe Renal Dysfunction
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
Moderate Renal Dysfunction
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Occurrence of CRS
时间窗: 90 days
Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion
Occurrence of ICANS
时间窗: 90 days
Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion
Occurrence of Cytopenias
时间窗: 90 days
Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion
次要结局
未报告次要终点