The aim of this study was to evaluate the difference in the accuracy of CD34+ cell detection by immunomagnetic bead method and flow cytometry in patients with hematologic malignancies pre-treated with stem cell transplantation after mobilization, and the results were compared simultaneously in the groups applying different mobilization protocols.
Treatment programs The mobilization protocol is. 1. etoposide 0.1 grams per square meter qd d1-3 2. algocytidine 0.5 grams per square meter q12h d1-3 3. whitening injection (subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group on the second day after chemotherapy, and G-CSF 5ug/kg/d in the control group from the fifth day after chemotherapy until the end of collection). In both groups, routine blood tests were performed daily, and the percentage of CD34+ cells in peripheral blood was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if the percentage of CD34+ was \>0.1% and peripheral blood leukocytes were \>3.5×109/L. Collection was stopped when the CD34+ cell count was \>5×106/kg, and no more than three attempts were made. Collection was considered a failure when CD34+ cells collected in any of the three attempts did not reach 2×106/kg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Total CD34+ cell yield (106/kg)
Total CD34+ cell yield (106/kg)
Time frame: through study completion, an average of 1 year
Accuracy differences between immunomagnetic bead assays and flow cytometry assays
Differences in the accuracy of immunomagnetic bead assay and flow cytometry in the detection of CD34+ cells after mobilization in lymphoma patients prepped for stem cell transplantation
Time frame: through study completion, an average of 1 year
Height
height in meters
Time frame: One day before chemotherapy
Weight
Weight in kg
Time frame: One day before chemotherapy
Vital signs and physical examination
Exclude unrelated organic disease by imaging studies
Time frame: One day before chemotherapy
ECOG score (d1 pre-chemotherapy)
The ECOG scoring standard (Eastern Cooperative Oncology Group) is an index to understand the patient's general health status and tolerance to treatment from the patient's physical strength. The patient's activity status is divided into 6 grades from 0 to 5, with higher scores indicating worse outcomes.
Time frame: One day before chemotherapy
Blood routine
Blood routine: Blood routine was tested daily, and peripheral blood CD34+ cell percentage was monitored from the time leukocytes started to rise after the nadir by immunomagnetic bead assay and flow cytometry, and collection was initiated if CD34+ percentage was \>0.1% and peripheral blood leukocytes were \>3.5×109/L.
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Time frame: Blood routine was tested daily, an average of 1 year
Adverse event record
Adverse event record: record any adverse events that occurred during the drug administration.
Time frame: through study completion, an average of 1 year