Autologous adoptive T cell
immunotherapy has been recognized as an effective treatment for
cancer patients. The initial qualified lymphocytes is the core
element determining the immunotherapeutic outcomes clinically. Cell separator based
apheresis procedure is an optimal procedure to collect adequate mono-nucleated lymphocytes to generate efficient ex vivo T cell expansions; however, potential
catheter-associated femoral vein
thrombosis at post-
apheresis might rise an additional deteriorated morbidity for
cancer patients. The emerging prophylactic medications are required at such circumstances. Therefore this study was designed to compare the prophylactic effects of
rivaroxaban versus
low molecular weight heparin (
LMWH) in patients who had exposed during the femoral vein catheterization for
apheresis. 74 Patients were randomized 1:1:1 into three groups:
subcutaneous injection of
LMWH,
Fraxiparine (n = 23) (0.4 ml, 3800 IU/day) for 2 days, oral
rivaroxaban 10 mg/d (n = 26), and oral
rivaroxaban 20 mg/d (n = 25) for consecutive 2 days. The primary endpoint was to compare the
venous thromboembolism (VTE) occurrence cases in one month post catheterization. There were 4 cases confirmed VTE occurrence in
LMWH group with contrast to 1 case in
rivaroxaban 10 mg administration group. None was seen in
rivaroxaban 20 mg group (P = 0.02 as the comparison with
LMWH). Meantime there was no
bleeding events occurrence afterwards. Oral
rivaroxaban 20 mg/day was recommendable to be considered which superior to
LMWH. Although these limited data and patient volume reached the statistical difference which was able to provide the evidence proofed to compare the potency of those two
anticoagulants, it could be regarded as the preliminary data provide the clinical results for
cancer patients who were placed in the condition of
apheresis and subsequently undergone adoptive T cell
immunotherapy.Trial registration ClinicalTrials.gov identifier, NCT03282643. Registered 16 February 2016, http://www.ClinicalTrials.gov/ NCT03282643.