Charles Gaulin: Phase 2 trial of ibrutinib in previously untreated high-risk smoldering mantle cell lymphoma
Charles Gaulin, Hematologic Oncologist at Dartmouth Hitchcock Medical Center and Clinics, shared his recent article on LinkedIn:
“Excited to share our recently published phase 2 trial of ibrutinib in previously untreated high-risk smoldering mantle cell lymphoma.
While the majority of MCL patients experience an aggressive disease course requiring prompt systemic therapy, 10–20% of patients present with indolent or smoldering disease that can be safely observed. A subset of these patients who are candidates for initial observation exhibit high-risk features and are of particular concern as they have a propensity to progress.
We therefore explored whether early intervention with ibrutinib could delay disease progression in patients with high-risk smoldering MCL that would otherwise be candidates for observation (n=20). With a 24-month progression-free survival of 95% and a manageable safety profile, our results suggest that ibrutinib may offer a promising strategy to manage high-risk smoldering MCL, potentially delaying the need for more intensive therapies.
Although our study was limited by its single-arm design and small cohort size, the data emphasize the potential of targeted therapy in this subset of MCL patients. Randomized trials like the ZEBRA study (NCT05635162) will be essential to validate these findings and determine the impact of early treatment with targeted therapy in these patients compared to observation.
Additional validated risk stratification methods are also needed to tailor follow-up strategies, improve prognostication, and guide the development of personalized treatment approaches for those at higher risk of progression in the era of newer therapies.
Authors: Charles Gaulin, Preetesh Jain, Ranjit Nair, Swaminathan P iyer, Hun Ju Lee, Luis E. Fayad, Lei Feng, Chi Young Ok, Rashmi Kanagal-Shamanna, Onyeka Oriabure, Wendy Chen, Guofan Xu, Anita Deswal, Cezar Iliescu, Maria Badillo, Michelle Ky, Michelle Avellaneda, Guilin Tang, L. Jeff Medeiros, Francisco Vega, Christopher R. Flowers, Michael Wang.
Manuscript: Phase 2 trial of ibrutinib in previously untreated high-risk smoldering mantle cell lymphoma
Funding: Pharmacyclics, an AbbVie Company
Phase 2 trial of ibrutinib in previously untreated high-risk smoldering mantle cell lymphoma.
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