A Single-arm Prospective Trial of Axicabtagene Ciloleucel (Axi-cel) Retreatment in Relapsed/Refractory Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Best objective response rate
研究概览
简要总结
This is a prospective, single-arm, clinical study to explore the efficacy and safety of Axi-cel retreatment in R/R LBCL in Shanghai Ruijin Hospital in China.
R/R LBCL patients who treated with Axi-cel got non-CR or relapsed were eligible for Axi-cel retreatment in this study. Patients will receive the standard dose of Axi-cel and follow the standard process. Other related treatment like bridging therapy or combination therapy will be based on patients status and investigators' decision. The primary endpoint is ORR, the secondary endpoint is CR, PR, DOR, PFS, OS and AE. A total of 32 patients is planned to be enrolled in this study. The trial will not go on if nobody got CR or PR in first 6 patients.
详细描述
This study is a prospective, single-arm, open-label two-stage study. There were 6 cases enrolled in Phase 1 and 26 cases enrolled in Phase 2, for a total of 32 cases.
This study aimed to collect data on efficacy and safety after secondary infusion treatment with aquilencel in adult patients with r/r LBCL after the first treatment of CD19 CAR-T. No form of grouping was performed in this study, and subgroup analyses were performed based on the actual data collected.
Research Process:
The patient has been evaluated for disease after the first treatment of akilencel, and the investigator decided to give the patient a second treatment based on clinical practice. Obtain informed consent before the second treatment of CD19 CAR-T, collect data on the patient's disease status before the second dose, previous and current decontamination treatment and other related treatments, and perform imaging tests such as positron emission tomography and computed tomography (PET-CT) or electronic computed tomography (CT) on the same day, day 15, day 29, month 3 after secondary administration, and 6, 9, 12, 18 and 24 months after secondary administration to confirm the collection of efficacy data, and investigators evaluated data on adverse events related to CD19 CAR-T, related laboratory results, etc.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent Form (ICF);
- •Adults with diagnosed relapsed or refractory Large B-cell lymphoma who have completed initial treatment with Axi-cel;
- •non-CR or relapsed after the initial Axi-cel infusion;
- •CD19 status by lymphoma lesion biopsy is at the discretion of investigators.
- •Antidrug antibodies (ADA) of Axi-cel should be performed prior to retreatment. 6) Lymphodepleting chemotherapy (fludarabine and cyclophosphamid) related toxicities were ≤ grade 1 or at the base line of Axi-cel initial treatment.
- •8）No serious adverse events occurred during the initial Axi-cel treatment or the adverse events in the first treatment period have recovered.
排除标准
- •Patients with hypersensitivity to any active ingredient or excipients (dimethyl sulfoxide, compound electrolyte injection, human albumin);
- •Uncontrolled systemic fungal, bacterial, viral, or other infections
研究组 & 干预措施
Axi-cel
Patients will receive a target dose of 2×10⁶ Axi-cel per kilogram of body weight after receiving a conditioning regimen. The conditioning regimen and dosage will be at investigator's discretion based on patient's status.
干预措施: axi-cel (Drug)
结局指标
主要结局
Best objective response rate
时间窗: Up to 2 years
ORR, defined as the incidence of either a complete response or a partial response assessed by investigators according to Lugano 2014 criteria.
次要结局
- Duration of Response (DOR)(Up to 2 years)
- Progression-Free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Complete response (CR) rate(Up to 2 years)