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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puzolcabtagene Autoleucel Injection | Drug | An autologous T-cell suspension expressing the CD19 chimeric antigen receptor（CD19 CAR-T) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate after Puzol-cel infusion [Effectiveness] | Objective response rate includes CR, CRi | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal residual disease（MRD） | MRD-negative ORR within 2 years by flow cytometry as assessed by investigator. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Assess the Children's growth and development after Puzol-cel infusion |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), regardless of gender.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Pan | Contact | 010-63290606 | panj@gobroadhealthcare.com |
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bone marrow samples, peripheral blood samples, cerebrospinal fluid samples
| 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 | 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 | 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) | 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. | 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 | 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 | 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. | 2 years |
| the incidence of RCL of Puzol-cel infusion | RCL Detection: the incidence of Replication Competent Lentivirus. | 2 years |
The subject's height were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter. |
| 2 years |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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