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Cancer Immunotherapy - ClinicalTrials.gov

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Last Updated: 10 May 2022

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Consolidation With ADCT-402 (Loncastuximab Tesirine) After a Short Course of Immunochemotherapy: a Phase II Study in BTKi-treated (or BTKi Intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Patients

This is a Phase 2, multicenter, open-label, single-arm study assessing the effectiveness and safety of loncastuximab tesirine as consolidation therapy in BTKi-treated R/R MCL patients. After salvage immunochemotherapy's consolidation, patients with loncastuximab tesirine will have complete reaction or partial response, or with stable disease after rescue immunochemotherapy will resume following consolidation. Total accrual period: 24 months The last patient enrolled in treatment was admitted, but it was expected that the following patient would have been enrolled. Patients who died after salvage immunochemotherapy were in danger of suffering CR, PR, or SD. There has been a period of induction with two cycles of 28 days with R-BAC + two weeks for restaging + 4 doses of loncastuximab tesirine every 21 days, i. e. , a total period of 22 weeks. CONSOLIDATION PHASE: After restaging at the End of Induction, patients with CR, PR, or SD will be able to receive two infusions of loncastuximab tesirine at a dose of 75 micorgram/kg* every three weeks, followed by two infusions of loncastuximab tesirine at a rate of 75 micorgram/kg* every three weeks. The lower limit of the 90 percent confidence interval of the 12-month PFS must be higher than the null hypothesis of 0. 30 to conclude that the new treatment is promising for a subsequent phase III research.

Source link: https://clinicaltrials.gov/ct2/show/NCT05249959

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions