Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)
Recruiting
Phase 3
Interventional Study
T-cell Lymphoblastic Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 Months – 18
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Children's Cancer Group, China · Research network
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About This Trial
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…
Trial Locations
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Eligibility 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 day…
Contacts