In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R)B-ALL. The available data suggest that the advancement of immunotherapy from R/R field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph+ ALL patients achieving complete remission (CR) with overembatinib, venetoclax and reduced-intensity chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.
The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation domain of 4-1BB, and the infusion dose was 1×10\^6/kg CAR+ cells in a single infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
CAR-T cells as consolidation therapy
BCL2 inhibitor
TKI
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGDisease-free Survival (DFS)
From CR1 to relapse, death from any cause or last follow-up
Time frame: Up to 2 years post-registration
Overall survival (OS)
From the date of registration to the date of death resulting from any cause.
Time frame: Up to 5 years post-registration
Event-free survival (EFS)
From the date of registration to the date of induction failure, relapse, death from any cause, or last follow-up
Time frame: Up to 5 years post-registration
Cumulative rate of complete molecular response
The cumulative rate of patients achieving complete molecular remission
Time frame: Up to 1 year post-registration
MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements
No clonal IG/TR rearrangements were detected by NGS
Time frame: Up to 1 year post-registration
Cumulative incidence of relapse (CIR)
Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk.
Time frame: Up to 2 years post-registration
The rate of adverse
adverse events during the treatment
Time frame: Up to 5 years post-registration
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