A prospective collection of data on the treatment of Chinese patients with relapsed/refractory follicular lymphoma (FL) using Axicabtagene Ciloleucel Injection, and evaluation of the efficacy and safety of Axicabtagene Ciloleucel Injection in this treatment.
This study is a single-arm, multicenter, prospective Phase II clinical trial, planning to enroll 30 Chinese subjects with relapsed/refractory follicular lymphoma (R/R FL) who will receive Axicabtagene Ciloleucel Injection. The study aims to assess the efficacy and safety of Axicabtagene Ciloleucel Injection in treating Chinese patients with R/R FL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Pre-treatment chemotherapy: Cyclophosphamide 500 mg/m² and Fludarabine 30 mg/m² will be administered intravenously on Days -5, -4, and -3 (with the day of Axicabtagene Ciloleucel Injection infusion being Day 0). Axicabtagene Ciloleucel Injection infusion: A single dose of autologous T cells transduced with chimeric antigen receptor (CAR) in the form of Axicabtagene Ciloleucel Injection will be administered to the subject intravenously. The target dose is 2.0×10\^6 anti-CD19 CAR-T cells/kg body weight. The minimum dose that can be used is 1.5×10\^6 anti-CD19 CAR-T cells/kg body weight. For subjects with a body weight of ≥100 kg, the maximum total dose is 2.0×10\^8 anti-CD19 CAR-T cells
Bing Xu
Xiamen, Fujian, China
RECRUITINGBest Objective Response Rate (bORR) at 6 months
This is defined as the proportion of subjects in the modified Intent-To-Treat (mITT) analysis set who achieve a best response of Complete Remission (CR) or Partial Remission (PR) following infusion of Axicabtagene Ciloleucel Injection, as determined by the treating physician, and who have the opportunity to complete the 6-month assessment. Before the data cutoff date, all subjects who do not meet the criteria for objective response will be considered as having no objective response (e.g., those without valid assessments or who did not undergo efficacy evaluation).
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Defined as the time interval from the date of Axicabtagene Ciloleucel Injection infusion to the date of disease progression or death due to any cause (whichever occurs first) in the modified Intent-To-Treat (mITT) analysis set.
Time frame: Up to 36 months
Complete Response (CR) Rate
Defined as the proportion of subjects in the modified Intent-To-Treat (mITT) analysis set who achieve a best response of Complete Response (CR) as determined by the treating physician.
Time frame: Up to 36 months
Partial Response (PR) Rate
Defined as the proportion of subjects in the modified Intent-To-Treat (mITT) analysis set who achieve a best response of Partial Response (PR) as determined by the treating physician.
Time frame: Up to 36 months
Duration of Response (DOR)
Defined as the time interval from the first documented complete or partial response to disease progression or death due to any cause (whichever occurs first) among subjects who achieve an objective response in the modified Intent-To-Treat (mITT) analysis set.
Time frame: Up to 36 months
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Overall Survival (OS)
Defined as the time interval from the infusion of Axicabtagene Ciloleucel Injection to death due to any cause in the modified Intent-To-Treat (mITT) analysis set. All subjects, regardless of whether they receive any additional anti-tumor treatment after infusion, will be followed up for survival information. The causes of death will also be reported.
Time frame: Up to 36 months