Clinical efficacy and safety of CLAE regimen for refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma: a prospective, multicenter, single-arm study
10.3760/cma.j.cn121090-20250123-00043
- VernacularTitle:CLAE方案治疗难治/复发急性T淋巴细胞白血病/淋巴瘤的疗效和安全性：一项前瞻性、多中心、单臂临床研究
- Author:
Yan LI
1
;
Xian ZHANG
;
Xiuhua SUN
;
Jia SONG
;
Rong ZHANG
;
Ping YANG
;
Wei WAN
;
Fei DONG
;
Jijun WANG
;
Hongmei JING
Author Information
1. 北京大学第三医院，北京 100191
- Publication Type:Journal Article
- Keywords:
Precursor T-cell lymphoblastic leukemia-lymphoma;
Recurrence;
Refractory Diseases;
Cladribine;
Cytarabine;
Etoposide
- From:
Chinese Journal of Hematology
2025;46(11):1005-1013
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy and safety of the CLAE (cladribine + cytarabine + etoposide) regimen in refractory/relapsed T cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) .Methods:Patients with R/R T-ALL/LBL received the CLAE regimen in a prospective, multicenter, single-arm clinical study or compassionate use. From March 2019 to August 2024, data from 25 patients (18 in the study across five centers and 7 receiving compassionate treatment in Peking University Third Hospital) were collected. Outcomes included objective response rate, complete response (CR) rate, partial response (PR) rate after 1–2 cycles, bridging to allo-HSCT, progression-free survival (PFS), overall survival (OS), and treatment-related adverse effects.Results:Median age was 29 years (range, 13–63) ; 17 were male. Among the 24 evaluable patients, CR rate was 33.3% overall and 41.2% among enrolled patients. Median OS and PFS time were 199 (46–1 310) and 49 (28–1 310) days, respectively. Cumulative OS rate at 6 months, 1 year, and 2 years was (52.1±10.2) %, (29.7±9.3) %, and (27.1±9.1) %, respectively; cumulative PFS rate was (32.6±9.6) %, (24.9±8.9) %, and (23.8±8.7) %, respectively. Among patients achieving CR or PR (8 cases), median OS and PFS were not reached. Cumulative OS rate at 6 months, 1 year, and 2 years was (86.8±12.0) %, (78.3±14.6) %, and (72.9±15.7) %, respectively, and the cumulative PFS rate was (86.4±12.1) %, (74.8±15.3) %, and (72.9±15.7) %, respectively. Adverse events were mainly hematologic; no treatment-related mortality occurred. Seven patients achieving CR were bridged to allo-HSCT, with 5 remaining in continuous remission.Conclusion:The CLAE regimen is safe and effective for R/R T-ALL/LBL, facilitating CR as a bridge to allo-HSCT and potentially improving patient prognosis.
