To assess the feasibility of oral dasatinib pulses (3 consecutive days per week) during the first month following infusion of brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
3 pulses of oral dasatinib (100 mg daily) beginning on Day 4 (+up to 2 days) for 3 days (with 4 days off), repeated weekly. The weekly 3-day pulse schedule of dasatinib may continue for up to 3 months in subjects who continue to meet the dasatinib eligibility criteria and who do not meet off treatment/off study criteria
Stanford University
Palo Alto, California, United States
Feasibility of dasatinib pulses
Feasibility of administering oral dasatinib pulses (3 consecutive doses per week) during the first month following Tecartus infusion. Feasibility will be defined as the ability of 8 out of 20 subjects to miss no more than one cycle (defined as one week of at least three consecutive days of dasatinib) within the first month following Tecartus infusion.
Time frame: 1 month
Safety of oral dasatinib pulses
Defined by a description of adverse events and serious adverse events at least possibly related to dasatinib following CAR T cell therapy; it will include an analysis of the sequential toxicity boundaries in that the analysis does not lead to a pause in the study; further defined as no reports of suspected death on study.
Time frame: 2 years
Overall response rate
The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).
Time frame: 3 months
Complete Response (CR)
The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).
Time frame: 3 months
MRD-negative Complete Response (CR)
The definitions for response are primarily based on the standardized response criteria defined by National Comprehensive Cancer Network (NCCN) Guidelines (NCCN, 2021 v.2).
Time frame: 3 months
Duration of CR in responders
Time frame: 2 years
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Progression Free Survival (PFS) following Tecartus plus dasatinib
PFS is defined as the time from the start of the investigational therapy to the date of radiographic progression
Time frame: 2 years
Overall Survival (OS) following Tecartus plus dasatinib
OS is defined as the time from the date of initial disease diagnosis to the date of death from any cause
Time frame: 2 years