ENCERT: A Multisite Phase 1 Trial Using Everolimus in Combination With Nelarabine, Cyclophosphamide, and Etoposide in Relapsed T-Cell Lymphoblastic Leukemia/Lymphoma.
Himalee S Sabnis, Melinda Pauly, Eric S Schafer et al.
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In 30 seconds
This multisite Phase 1 trial assessed the safety and efficacy of everolimus combined with nelarabine, cyclophosphamide, and etoposide in children and young adults with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma. The study found an overall response rate of 75% (6/8), with 100% response in the T-ALL cohort.
Key findings
- The overall response rate was 75% (6/8) among participants.
- In the T-ALL cohort, the response rate was 100% (5/5).
- In the T-LL cohort, the response rate was 33% (1/3).
- No dose-limiting toxicities were reported at the highest dose tested.
Why it matters
The findings suggest that the combination of everolimus with NEC chemotherapy may be a promising approach for achieving remission in relapsed/refractory T-ALL/T-LL, a challenging condition with limited treatment options.