Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)

T-cell lymphoblastic lymphoma (T-LBL) is the second most common subtype of non-Hodgkin lymphoma (NHL) in children and adolescents. With current treatment, event-free survival (EFS) rates vary between 75%\~85%. Two different MTX intensification strategies are used commonly: HD-MTX with leucovorin rescue, and Capizzi-style MTX without leucovorin rescue plus PEG-ASP (C-MTX). Although superior outcome of patients with T-ALL receiving C-MTX compared with HD-MTX on the AALL0434 trial, the 2 approaches had not been compared directly in patients with T-LBL. There remains controversy on PET/CT interpretation in children with NHL. Large prospective studies in pediatric patients with T-LBL regarding PET/CT value for this is scarce. Around 1% pediatric patients with T-LBL will not achieve remission at the end of Induction (induction failure). The optimal treatment for this small subgroup is largely unclear. The BFM HR Blocks usually are applied to these patients even though the efficacy is unknown. Novel targeted therapies are needed for use. Dasatinib is identified as a targeted therapy for T-cell ALL in preclinical drug screening.

NCT Number	NCT05681260
Lead Sponsor	Children's Cancer Group, China Collaborators: Shanghai Children's Medical Center, Beijing Children's Hospital, Children's Hospital of Scow University, West China Second University Hospital, Nanjing Children's Hospital, Qilu Hospital of Shandong University, Tianjin Medical University Cancer Institute and Hospital, Tongji Hospital, Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University, Cancer hospital of Shandong Province, Shenzhen Children's Hospital, Wuhan Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, Shanghai Children's Hospital, Ruijin Hospital, The Second Hospital of Anhui Medical University, Children's Hospital of Hebei Province, Cancer Hospital of Henan Province, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Qilu Children's Hospital
Conditions	T-cell Lymphoblastic Lymphoma
Enrollment	200 participants
Start Date	2023-02-06
Primary Completion	2026-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-19