Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL)
Conditions
Keywords
Puzolcabtagene Autoleucel Injection
Brief summary
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
DRUGPuzolcabtagene Autoleucel Injection
An autologous T-cell suspension expressing the CD19 chimeric antigen receptor（CD19 CAR-T)
Sponsors
Chongqing Precision Biotech Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate after Puzol-cel infusion [Effectiveness] | 2 year | Objective response rate includes CR, CRi |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal residual disease（MRD） | 2 years | MRD-negative ORR within 2 years by flow cytometry as assessed by investigator. |
| Best overall response after Puzol-cel infusion [Effectiveness] | 2 years | 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] | 2 years | 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] | 2 years | 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 |
| Relapse free survival after Puzol-cel infusion [Effectiveness] | 2 years | Relapse free survival means time from subject infusion of Puzol-cel to first disease relapse or death from any cause (whichever occurs first) |
| Event free survival after Puzol-cel infusion [Effectiveness] | 2 years | 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. |
| The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel | 2 years | Number of participants with adverse events as assessed by CTCAE v5.0 |
| the incidence of adverse events related to treatment of Puzol-cel infusion | 2 years | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
| the incidence of adverse event of special interest (AESI) of Puzol-cel infusion | 2 years | 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. |
| the incidence of RCL of Puzol-cel infusion | 2 years | RCL Detection: the incidence of Replication Competent Lentivirus. |
Contacts
CONTACTJing Pan
Outcome results
None listed