Actively Recruiting
Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)
Led by Children's Cancer Group, China · Updated on 2026-03-19
200
Participants Needed
2
Research Sites
360 weeks
Total Duration
On this page
Sponsors
C
Children's Cancer Group, China
Lead Sponsor
S
Shanghai Children's Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed T-lineage lymphoblastic lymphoma (T-LBL) Stage II-IV
You will not qualify if you...
- 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 (prednisone or methylprednisone dose does not affect eligibility)
- Inhalation and topical steroids are not considered pretreatment
- A single dose of vincristine is allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
2
West China Second University Hospital
Chengdu, China
Not Yet Recruiting
Research Team
Y
Yi-Jin Gao, M.D.
CONTACT
Q
Qing Quan, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here