Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05970185
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-07-12
Brief Title:
The Value of Peripheral Blood CD34 Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization
Sponsor:
Zhongnan Hospital
Organization:
Zhongnan Hospital
Study Overview
Official Title:
Fuling Zhou Head Division of Hematology Professor of Hematology Doctoral Advisor Zhongnan Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Treatment programs The mobilization protocol is
1 etoposide 01 grams per square meter qd d1-3
2 algocytidine 05 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 5ugkgd 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 01 and peripheral blood leukocytes were 35109L
Collection was stopped when the CD34 cell count was 5106kg 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 2106kg
1 etoposide 01 grams per square meter qd d1-3
2 algocytidine 05 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 5ugkgd 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 01 and peripheral blood leukocytes were 35109L
Collection was stopped when the CD34 cell count was 5106kg 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 2106kg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None