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- Title
Efficacy and Safety of Children With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia After Anti-CD19 CAR T-Cell Therapy Without Bridging Transplantation.
- Authors
Shang, Qianwen; Xue, Lian; Lu, Aidong; Jia, Yueping; Zuo, YingXi; Zeng, Huimin; Zhang, Leping
- Abstract
This study aimed to explore the prognosis of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) after chimeric antigen receptor (CAR) T-cell therapies without bridging transplantation. The MRD status before CAR T-cell infusion was found to be associated with OS, EFS, and toxicity. Patients with MRD ≥1% constituted a distinct high-risk population that may benefit from additional interventions to optimize outcomes mediated by CAR therapy. Furthermore, patients who experienced CD19-negative relapse after infusion exhibited a less favorable OS outcome. Background: Anti-CD19 chimeric antigen receptor (CAR) T-cell therapies have demonstrated significant efficacy in achieving complete remission (CR) in pediatric patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). However, a considerable number of patients experience relapse within 1 year after CAR T-cell therapy, leading to an extremely poor prognosis, particularly in patients without bridging transplantation. Materials and Methods: In our study, we investigated 42 children with R/R B-ALL who underwent anti-CD19 CAR T-cell therapy without bridging transplantation at our center. All patients were included in the response analysis and evaluated for survival and toxicity. Results: The cohort that received the CAR T-cell infusion exhibited a 100% CR rate by day 28 (d28). The overall survival (OS) at 4 years was 61.3% ± 8.5%, and the event-free survival (EFS) was 55.9% ± 7.9%, with a median follow-up duration of 50.1 months. Minimal residual disease (MRD) ≥1% was associated with inferior outcomes, resulting in lower 4-year OS (P = .033) and EFS (P = .014) compared to MRD<1%. The incidences of grade ≥3 cytokine release syndrome (CRS) and neurotoxicity were 26.8% and 23.8%, respectively. Furthermore, MRD >1% was identified as an independent factor associated with increased severity of CRS and occurrence of neurotoxicity. Conclusion: These findings suggest that reducing the pre-infusion MRD could serve as an effective treatment strategy to enhance the outcomes of CAR T-cell therapy.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2024, Vol 24, Issue 6, p392
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/j.clml.2024.02.002