This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).
UKM Medical Centre
Bandar Tun Razak, Kuala Lumpur, Malaysia
RECRUITINGOverall response rate (ORR)
Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.
Time frame: Participants will be followed for the duration of the treatment, with an expected average of 3 months.
Complete response (CR)
Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.
Time frame: 12 Months
CR with incomplete blood recovery (CRi).
Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.
Time frame: 12 Months
Overall survival (OS)
Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.
Time frame: 12 Months, 24 Months
Progression free survival (PFS)
Progression Free Survival (PFS) defined as the time from treatment to first documentation of objective leukemic progression (date of leukaemia assessment documenting progressive disease) or to death due to any cause. Progression is assessed by BM biopsy or CSF analysis according to NCCN criteria. It is assessed at Day 30 and monthly thereafter, or earlier if clinically indicated.
Time frame: 12 Months, 24 Months
Time to next treatment (TTNT)
Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy.
Time frame: 12 Months, 24 Months
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Percentage of adverse events
Percentage of participants with adverse events
Time frame: 30 days