Establishing real-world data of Chinese patients with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) treated with Puzolcabtagene Autoleucel Injection to evaluate its effectiveness.
Best Overall Response (BOR), including CR and CRi(CR: Complete Remission; CRi: Complete Remission with incomplete hematologic recovery)、Best Complete Remission Rate (CRR)、MRD-negative Objective Response Rate (MRD: Minimal Residual Disease)、Duration of Response (DOR)、Relapse-Free Survival (RFS)、Overall Survival (OS)
Study Type
OBSERVATIONAL
Enrollment
200
An autologous T-cell suspension expressing the CD19 chimeric antigen receptor（CD19 CAR-T)
Objective response rate after Puzol-cel infusion [Effectiveness]
Objective response rate includes CR, CRi
Time frame: 2 year
Minimal residual disease（MRD）
MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.
Time frame: 2 years
Best overall response after Puzol-cel infusion [Effectiveness]
Best overall response means the proportion of patients with the best efficacy (CR or CRi) after Puzol-cel therapy.
Time frame: 2 years
Overall survival after Puzol-cel infusion [Effectiveness]
Overall survival means the time from infusion of Puzol-cel to death of subjects from any cause
Time frame: 2 years
Duration of response after Puzol-cel infusion [Effectiveness]
Duration of response means the time from first assessment of CR or CRi to first assessment of disease recurrence or death from any cause, whichever occurs first
Time frame: 2 years
Relapse free survival after Puzol-cel infusion [Effectiveness]
Relapse free survival means time from subject infusion of Puzol-cel to first disease relapse or death from any cause (whichever occurs first)
Time frame: 2 years
Event free survival after Puzol-cel infusion [Effectiveness]
Event free survival means the time from the infusion of Puzol-cel to the time of the following events (whichever occurs first): a. Death from any cause after remission; b. Disease recurrence; c. Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 years
The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: 2 years
the incidence of adverse events related to treatment of Puzol-cel infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 2 years
the incidence of adverse event of special interest (AESI) of Puzol-cel infusion
Number of participants with special interest adverse events as assessed by CTCAE v5.0,The following adverse events were defined as adverse events of special interest for this study: a.Cytokine release syndrome (CRS) of grade 3 and above; b. Immune effector cell-associated neurotoxicity syndrome (ICANS) of grade 3 and above; c.Grade 3 and above infection; d.Grade 3 and above acute tumor lysis syndrome; e.Unresolved cytopenias lasting 28 days.
Time frame: 2 years
the incidence of RCL of Puzol-cel infusion
RCL Detection: the incidence of Replication Competent Lentivirus.
Time frame: 2 years