The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle. Children: 14 daily intramuscular injections 200mg/m\^2 of Interferon-α for a 28-day cycle. CAR T cell: (1-2)×10\^7/kg, intravenously infusion.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time frame: 2 years
Overall survival (OS)
time from enrollment to the date of death from any cause
Time frame: 2 years
Leukemia-free survival (LFS)
time from enrollment to the date of primary refractory disease, or relapse from CR, or death from any cause
Time frame: 2 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Time frame: 2 years
the duration of CAR-T cells in patients
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Time frame: 2 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.