NCT05970185

The Value of Peripheral Blood CD34+ Cell Dynamics Monitoring in Autologous Hematopoietic Stem Cell Transplant Mobilization

Fuling Zhou, Head, Division of Hematology; Professor of Hematology; Doctoral Advisor, Zhongnan Hospital

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zhongnan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Granulocyte Colony-Stimulating Factor

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF	Subcutaneous injection of polyethylene glycolized recombinant human granulocyte-stimulating factor injection 6mg bid in the experimental group the day after the end of chemotherapy
DRUG	G-CSF	G-CSF 5ug/kg/d from day 5 after the end of chemotherapy until the end of collection

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2023-08-01
• Last updated: 2024-01-18

Locations

1 site across 1 country: China