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

• Status: Not yet recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Cancer Group, China
• Collaborators: Beijing Children's Hospital; Cancer Hospital of Henan Province; Cancer hospital of Shandong Province; Children's Hospital of Hebei Province; Children's Hospital of Scow University; Nanjing Children's Hospital; Qilu Children's Hospital; Qilu Hospital of Shandong University; Ruijin Hospital; Second Affiliated Hospital of Anhui Medical University; Shanghai Children's Hospital; Shanghai Children's Medical Center; Shenzhen Children's Hospital; Sun Yat-Sen Memorial Hospital Zhongshan University; The First Affiliated Hospital of Zhengzhou University; Tianjin Medical University Cancer Institute and Hospital; Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; West China Second University Hospital; Wuhan Children's Hospital; Xiangya Hospital of Central South University; Zhejiang University School of Medicine Children's Hospital
• Treatments: Asparaginase; BB 1101; Bortezomib; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone acetate; Doxorubicin; Etoposide; Ifosfamide; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Pegaspargase; Prednisone; Vincristine; Vindesine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.