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Clinical Trial Summary

Study is a phase I study to determine the maximum tolerated dose of adding Loncastuximab Tesirine to Aclabrutinib in the treatment of chronic lymphocytic leukemia.


Clinical Trial Description

The study is a phase I study which will employ the Bayesian optimal interval (BOIN) design to find the maximum tolerated dose (MTD). Approximately 24 Dose-Limiting Toxicity (DLT) evaluable participants will be treated to find MTD with a target DLT rate of 25%, and 4 pre-specified doses. The total number of participants enrolled will depend on the frequency of DLTs and when the MTD is determined. The maximum number of patients at a given dose level is 12. The dose of acalabrutinib will be fixed and loncastuximab tesirine will be titrated as in dose level table 1 below. Table 1. Dose levels Dose Level Schedule 1. 45 µg/kg Loncastuximab Tesirine + Acalabrutinib 100 mg BID 2. 60 µg/kg Loncastuximab Tesirine + Acalabrutinib 100 mg BID 3. 75 µg/kg Loncastuximab Tesirine + Acalabrutinib 100 mg BID 4. 90 µg /kg Loncastuximab Tesirine (for first 2 cycles followed by 75µg/kg for subsequent cycles) + Acalabrutinib 100 mg BID The DLT evaluation period is two cycles (42 days). Loncastuximab Tesirine will be given as an IV infusion, each cycle is a 21 day cycle, with Loncastuximab Tesirine given day 1 of each cycle. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05971251
Study type Interventional
Source University of Alabama at Birmingham
Contact Pamela M Hardwick
Phone 2059755387
Email pamdixon@uab.edu
Status Recruiting
Phase Phase 1
Start date December 18, 2023
Completion date December 31, 2028

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