This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tecartus is a CD19 directed CAR T-cell therapy that utilizes CD28 costimulatory and CD3 zeta stimulatory domains. Tecartus is manufactured from purified autologous T-cells via retroviral transduction with a median time to product release of 13 days.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGRelapse Free Survival (RFS)
The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Time frame: Up to 5 years
Molecular Response Rate
Measured as converting to a complete molecular remission following CAR T-cell immunotherapy. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.
Time frame: Up to 5 years
Clinical Relapse Rate
Measured as \>5% lymphoblasts in the bone marrow and/or the emergence of extramedullary leukemia.
Time frame: Up to 5 years
Molecular Relapse Rate
Measured as achieving complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.
Time frame: Up to 5 years
Duration of Response (DOR)
Measured as time from enrollment until clinical relapse or death. In the case of death without documented relapse, patients will be censored.
Time frame: Up to 5 years
Molecular Relapse Free Survival (MRFS)
Measured by complete molecular remission at day 28 and followed until 5 years from infusion or the emergence of detectable disease. Molecular remission is defined as having fewer than 0.0001% clonotype sequences per one million nucleated cells.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 5 years
Overall Survival
Measured as time from date of enrollment to date of death from any cause.
Time frame: Up to 5 years
Rate of Cytokine Release Syndrome (CRS)
Participants rate of developing Cytokine Release Syndrome (CRS)
Time frame: Up to 5 years
Rate of Immune effector cell-associated neurotoxicity syndrome (ICANS)
Participants rate of developing Immune effector cell-associated neurotoxicity syndrome (ICANS).
Time frame: Up to 5 years