NCT05971251

Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia

Addition of loNcasTuxImab teSirine to AcalabruTinib in Chronic Lymphocytic Leukemia(Anti-Static Study)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Loncastuximab Tesirine and Acalabrutinib	Will be given on Day 1 of each cycle with each cycle being 21 days, and is being added to BID Acalabrutinib

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-08-02
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study