Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed follicular lymphoma (FL) grade 1, 2, or 3a according to WHO 2016 classification criteria
Subjects with relapsed or refractory FL after prior second-line or higher therapy Prior therapy must include: anti-CD20 monoclonal antibody in combination with an alkylating agent (anti-CD20 monoclonal antibody monotherapy is not eligible as a line of therapy for eligibility). Subjects who have had stable disease (no recurrence) for more than 1 year after completion of their last treatment do not meet the enrollment criteria Translated with DeepL.com (free version)
At least one measurable lesion according to the Lugano 2014 classification (Cheson 2014). Lesions with prior radiotherapy were considered measurable only if definitive progression was confirmed after completion of radiotherapy.
Patients with FL lymphoma secondary to central may be included in the
Disqualifiers
Converted FL
Small lymphocytic lymphoma
The histologic grading of FL was 3b
lymphoplasmacytic lymphoma
Trial design
Design model
Single group
Treatments tested in this trial
Axicabtagene Ciloleucel
DrugPre-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
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Axicabtagene Ciloleucel InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Best 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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov