Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT05971251
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2023-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Addition of Loncastuximab Tesirine to Acalbrutinib , Chronic Lymphocytic Leukemia
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Addition of loNcasTuxImab teSirine to AcalabruTinib in Chronic Lymphocytic Leukemia(Anti-Static Study)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 000549077 | OTHER | ADC Therapeutics | View |