Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Puzolcabtagene Autoleucel Injection.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-Interventional Study of Puzolcabtagene Autoleucel Injection for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Overview
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.
Detailed description
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)
Interventions
- Drug Puzolcabtagene Autoleucel Injection
An autologous T-cell suspension expressing the CD19 chimeric antigen receptor（CD19 CAR-T)
Primary outcome measures
- Objective response rate after Puzol-cel infusion [Effectiveness] [Time frame: 2 year]
Secondary outcome measures (10)
- Minimal residual disease（MRD） [Time frame: 2 years]
- Best overall response after Puzol-cel infusion [Effectiveness] [Time frame: 2 years]
- Overall survival after Puzol-cel infusion [Effectiveness] [Time frame: 2 years]
- Duration of response after Puzol-cel infusion [Effectiveness] [Time frame: 2 years]
- Relapse free survival after Puzol-cel infusion [Effectiveness] [Time frame: 2 years]
- Event free survival after Puzol-cel infusion [Effectiveness] [Time frame: 2 years]
- The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel [Time frame: 2 years]
- the incidence of adverse events related to treatment of Puzol-cel infusion [Time frame: 2 years]
- the incidence of adverse event of special interest (AESI) of Puzol-cel infusion [Time frame: 2 years]
- the incidence of RCL of Puzol-cel infusion [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients who test positive for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07637929 · PB14