A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children with Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed T-lineage lymphoblastic lymphoma (T-LBL) Stage II-IV

Locations
Other Locations
China
West China Second University Hospital
NOT_YET_RECRUITING
Chengdu
Shanghai Children's Medical Center
RECRUITING
Shanghai
Contact Information
Primary
Yi-Jin Gao, M.D.
gaoyijin@scmc.com.cn
0086-21-38087513
Backup
Qing Quan, M.D
yuanqing@scmc.com.cn
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Standard risk Arm A
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, Capizzi escalating methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.
Experimental: Standard risk Arm B
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who achieve at least a PR at the end of Induction (EOI). Induction I followed by consolidation, high dose methotrexate (interim maintenance) , delayed intensification and maintenance therapy. Triple intrathecal injections.
Experimental: High Risk T-LBL
Any pediatric patients with newly diagnosed T-LBL Stage II to IV who fail to achieve at least a PR at the end of Induction (EOI). Induction I followed by 6 intensive polychemotherapy blocks (HR1'-HR2'-HR3'-HR1'-HR2'-HR3'), deIayed intensification, and maintenance therapy. Triple intrathecal injections.
Sponsors
Collaborators: Wuhan Children's Hospital, Cancer hospital of Shandong Province, Second Affiliated Hospital of Anhui Medical University, Ruijin Hospital, Beijing Children's Hospital, Nanjing Children's Hospital, Shanghai Children's Hospital, Shenzhen Children's Hospital, West China Second University Hospital, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Qilu Children's Hospital, Zhejiang University School of Medicine Children's Hospital, Tongji Hospital, Cancer Hospital of Henan Province, Children's Hospital of Scow University, Children's Hospital of Hebei Province, Shanghai Children's Medical Center, Tianjin Medical University Cancer Institute and Hospital
Leads: Children's Cancer Group, China

This content was sourced from clinicaltrials.gov