A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.
The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL\< 25.65 umol/L, ALT and AST \< 2 times the upper limit of normal value;
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization
After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Mobilization success rate
Accumulate CD34+cells ≥ 2×106/kg for 3 times or less
Time frame: 48 months
White blood cell trough and peak
The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied
Time frame: 30 days
Speed of recovery
The number of days when the leucocyte trough rose to the peak
Time frame: 30 days
Time of highest point of CD34+ cells
Time of highest point of CD34+ cells
Time frame: 30 days
Single acquisition volume
Single acquisition volume
Time frame: 30 days
Acquisition times
Acquisition times
Time frame: 30 days
Administration times of rhG-CSF
Administration times of rhG-CSF
Time frame: 30 days
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