Comparing two methotrexate treatments for children with T-cell lymphoblastic lymphoma
Official title: 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)
Run by Children's Cancer Group, China · NCT05681260 · Data updated 2026-11-12
This study tests which of two methotrexate treatments works better for children with T-cell lymphoblastic lymphoma to help them stay healthy and improve their chances of recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Months to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Children's Cancer Group, China Research network |
| Drugs / interventions | chemotherapy, prednisone, Dasatinib, immunotherapy, radiation |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | February 6, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2029 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT05681260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and adolescents with newly diagnosed T-cell lymphoblastic lymphoma at stages II-IV.
✕Probably not a fit
Patients with Down syndrome, primary immune compromised disease, or those who have received prior cytotoxic chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of two methotrexate treatment strategies for children diagnosed with T-cell lymphoblastic lymphoma (T-LBL). One approach uses high-dose methotrexate with leucovorin rescue, while the other employs Capizzi-style methotrexate without leucovorin rescue. The study will evaluate event-free survival rates and the potential benefits of each treatment method. Additionally, it will explore the role of PET/CT imaging in assessing treatment response in pediatric patients with T-LBL.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and survival rates for children with T-cell lymphoblastic lymphoma.
How similar studies have gone: Previous studies have shown promising outcomes with similar methotrexate treatment strategies in related conditions, but this direct comparison in T-LBL is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China Recruiting -
West China Second University Hospital
Chengdu, China Not yet recruiting
Study contacts
- Principal investigator: Yi-Jin Gao, MD — Shanghai Children's Medical Center
- Study coordinator: Yi-Jin Gao, M.D.
- Email: gaoyijin@scmc.com.cn
- Phone: 0086-21-38087513
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.