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

Recruiting now · Phase 3

Conditions studied: T-cell Lymphoblastic Lymphoma

In brief

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.

Key facts

Study ID

NCT05681260

Run by

Children's Cancer Group, China

People needed

200

Starts

2023-02-06

Expected to finish

2029-12-31

Last updated by the study team

2026-03-19

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China (enrolling)
• West China Second University Hospital — Chengdu, China

Full record on ClinicalTrials.gov

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