This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
213
autologous or allogeneic peripheral blood lymphocytes
autologous or allogeneic cytokine-induced killer (CIK) cells
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Event-free survival(EFS) in CIK infusion group
EFS is defined as the time from CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure
Time frame: 2-year EFS rate
Progression-free survival(PFS) in CIK infusion group
PFS is defined as the time from CIK-cell infusion until objective tumor progression or death depending on study protocol
Time frame: 2-year PFS rate
Duration of response(DOR) in CIK infusion group
DOR is defined as the time interval from the earliest qualifying minimal residual disease-negative response \[i.e. complete remission(CR),complete remission with partial hematological recovery(CRh), complete remission with incomplete hematological recovery(CRi), morphologic leukemia-free state(MLFS), or aplastic marrow (patients with blood and bone marrow disease), central nervous system(CNS) remission (patients with CNS disease) and complete resolution of the lymphomatous enlargement by CT or positron emission tomography(PET)-CT negative (for patients with a previous positive PET-CT) (patients with lymphomatous extramedullary disease)\] to the date of relapse or death from any cause.
Time frame: from enrollment to the end of treatment at 15 years
Overall survival(OS) in CIK infusion group
OS is defined as the time from CIK-cell infusion to death from any cause.
Time frame: from enrollment to the end of treatment at 15 years
EFS in mRNA-CIK infusion group
EFS is defined as the time from mRNA-CIK-cell infusion to the earliest relapse, death from any cause, or treatment failure
Time frame: 2-year EFS rate
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