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839 Tucidinostat Plus Pediatric-Inspired Chemotherapy As First-Line Therapy for Newly Diagnosed ETP-ALL/Lbl: An Open-Label, Single-Arm, Phase 2 Trial

Program: Oral and Poster Abstracts
Type: Oral
Session: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Treatment of BCR:ABL+ and T Cell Diseases
Hematology Disease Topics & Pathways:
Research, Clinical trials, Clinical Research
Monday, December 9, 2024: 3:45 PM

Jieping Lin1*, Chenhao Ding1*, Zicong Huang1*, Cai Zihong1*, Jia Li1*, Zhixiang Wang1*, Xiaofang Li1*, Xuan Zhou1*, Bailin He2*, Wenhao Zhong1*, Li Xuan1*, Qifa Liu, MD2, Yang Xu3* and Hongsheng Zhou1,4,5*

1Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou, China
2Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China
3The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, China
4Guangdong Provincial Clinical Research Center for Hematologic Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China
5Department of Hematology, People's Hospital of Ganzhou, Ganzhou, China

Background Early T-cell precursor lymphoblastic leukemia/lymphoma (ETP-ALL/LBL) is a distinct subtype of T-ALL/LBL, with a dismal prognosis. The aim of this study was to investigate the effectiveness and safety of histone deacetylase inhibitor (HDACi) tucidinostat combined with pediatric-inspired chemotherapy for new diagnosed ETP-ALL/LBL.

Methods This phase 2 trial was conducted at Nanfang Hospital in China. Patients aged 14-55 years with newly diagnosed ETP-ALL/LBL were eligible. Patients received pediatric-inspired chemotherapy in combination with tucidinostat, which was orally administered once daily at a dosage of 10 mg from induction therapy to consolidation therapy. The primary endpoint was 3-year event-free survival (EFS). Secondary endpoints were overall survival (OS), relapse-free survival (RFS), complete remission rate and adverse events. This study is registered with ClinicalTrials.gov, number NCT03553238.

Findings From June 2018 to June 2022, 54 patients with ETP-ALL/LBL were enrolled (37 [68%] male; 17 [32%] female; 54 [100%] Asian; median age 24 years [IQR 19-31]). The composite complete remission (CRc, complete response [CR] plus complete response with incomplete blood count recovery [CRi]) rate and MRD negativity after induction therapy was 91% (49 of 54 patients) and 65% (35 of 54 patients), respectively. The MRD negativity after consolidation was achieved in 87% patients (47 of 54 patients). With a median follow-up of 39.3 months (IQR, 20.6 to 60.0), the 3-year EFS rate was 67.7% (95% CI 56.2–81.7), the 3-year OS rate was 71.5% (95% CI 60.2–84.9) and the 3-year RFS rate was 67.5% (95% CI 55.9-81.6). The most common grade 3-4 adverse events were neutropenia (94%), anemia (85%), thrombocytopenia (76%), infection (53%), and hypokalemia (21%).

Interpretation Tucidinostat plus pediatric regimen is an effective and well-tolerated regimen for new diagnosed ETP-ALL/LBL, with high CRc and MRD negativity rates, as well as encouraging survival outcomes.

Disclosures: No relevant conflicts of interest to declare.

OffLabel Disclosure: Tucidinostat is used as the initial treatment for newly diagnosed ETP-ALL/LBL.

See more of: 613. Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation: Treatment of BCR:ABL+ and T Cell Diseases
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