About this trial
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 criteria
Qualifiers
Newly diagnosed T-lineage lymphoblastic lymphoma (T-LBL) Stage II-IV
Disqualifiers
Patients with Down syndrome or primary immune comprised disease.
Ph+ T-LBL
Patients must not have received any prior cytotoxic chemotherapy
Any steroids pretreatment for > 5 days in the 7 days or for >14 days in the 28 days before the initiation of Induction chemotherapy. The dose of prednisone or methylprednisone pretreatment does not affect eligibility. Any steroids exposure that occurred > 28 days before the initiation of Induction chemotherapy is allowed. Inhalation and topical steroids are not considered pretreatment. A single dose of vincristine is allowed.
Trial design
Treatments tested in this trial
- Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin
- Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin
- Prednisone,Vincristine, Pegylated-asparaginase, Bortezomib,Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine, methotrexate, Dexamethasone, Doxorubicin, Vindesine, Etoposide, Ifosfamide
Treatment groups
Sponsors and collaborators
Children's Cancer Group, China
Lead sponsor
Shanghai Children's Medical Center
Collaborator
Beijing Children's Hospital
Collaborator
Children's Hospital of Scow University
Collaborator
West China Second University Hospital
Collaborator
Nanjing Children's Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Tongji Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Cancer hospital of Shandong Province
Collaborator
Shenzhen Children's Hospital
Collaborator
Wuhan Children's Hospital
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
Shanghai Children's Hospital
Collaborator
Ruijin Hospital
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Children's Hospital of Hebei Province
Collaborator
Cancer Hospital of Henan Province
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Qilu Children's Hospital
Collaborator