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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | 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 | Active Comparator | G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Total CD34+ cell yield (106/kg) | Total CD34+ cell yield (106/kg) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 1 year |
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Inclusion Criteria:
Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and cooperated with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuling Zhou | Contact | +862767813137 | zhoufuling@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fuling Zhou | Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| G-CSF | Drug | G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection |
|
| Height |
height in meters |
| One day before chemotherapy |
| Weight | Weight in kg | One day before chemotherapy |
| Vital signs and physical examination | Exclude unrelated organic disease by imaging studies | 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. | 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. | 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. | through study completion, an average of 1 year |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |