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.
Patients with r/r B-ALL who receive treatment with Pucicelant Injection at a research center commercially certified by Chongqing Precision Biotech in China, and whose bone marrow tumor cells are confirmed to express CD19 by flow cytometry
Patients with essentially normal function of vital organs
Patients who voluntarily participate in this study and sign the informed consent form. For patients under 18 years of age, informed consent must also be obtained from their legal guardians
Patients who test positive for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP).
Patients diagnosed with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), regardless of gender.
Case-only
Prospective
Puzolcabtagene Autoleucel Injection
DrugAn 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
Minimal residual disease（MRD）
MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.
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.
Overall survival after Puzol-cel infusion [Effectiveness]
Overall survival means the time from infusion of Puzol-cel to death of subjects from any cause
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
Comparative analysis of 6-month ORR of Puzol-cel treatment with or without hematopoietic stem cell transplantation
investigator-assessed ORR, including CR and CRi; investigator-assessed ORR with MRD-negative, including CR and CRi.
Assess the Children's growth and development after Puzol-cel infusion
The subject's height were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
