Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT05971251
Brief 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.
Study:
NCT05971251
Study Brief:
Protocol Section:
NCT05971251