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 relapsed/refractory (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- B-ALL patients achieving complete remission (CR) with 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
77
CAR-T cells as consolidation therapy
VEN
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
MRD-negative complete remission rate measured by flow cytometry.
No blasts were detected by flow cytometry when CR criteria were met after induction therapy.
Time frame: After induction (4 week)]
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
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 events
adverse events during the treatment
Time frame: Up to 5 years post-registration
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