Comparing two methotrexate treatments for children with T-cell lymphoblastic lymphoma
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)
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 |
| Enrollment | 200 (estimated) |
| Ages | 12 Months to 18 Years |
| Sex | All |
| 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) |
| Trial ID | NCT05681260 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents with newly diagnosed T-cell lymphoblastic lymphoma at stages II-IV.
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.
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 performed: Previous studies have shown promising outcomes with similar methotrexate treatment strategies in related conditions, but this direct comparison in T-LBL is novel.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.