Sponsor study identifier
interventional
160
1 country
3
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies. This prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF once daily for 4-5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures. The study protocol was substantially amended following approval by the Institutional Review Board. The amendments included revisions to the G-CSF administration regimen, the primary and secondary outcome measures, and the assessment schedule. Enrollment under the revised protocol commenced on 1st Nov. Participants enrolled under the previous protocol version will be documented separately and will not be included in the prespecified primary analysis of the revised-protocol cohort.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 13, 2026
Actual (reported)February 20, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Peripheral Blood CD34+ Cell Count before the first apheresis session
Peripheral blood CD34+ cell count (cells/μL) measured at a fixed clock time of 11:30 (±15 minutes), after the fourth G-CSF dose and immediately before the first apheresis session, scheduled to begin at 12:00 in both treatment groups. CD34+ cell counts will be determined using standardized flow cytometry procedures.
After the fourth G-CSF dose, immediately before the first apheresis session (11:30 ±15 minutes).
Peripheral Blood CD34+ Cell Count 12 Hours After the Third G-CSF Dose
12 (±1) hours after the third G-CSF dose, before the first apheresis session.
CD34+ Cell Yield During the First Apheresis Session
At completion of the first apheresis session following the fourth G-CSF dose.
Peripheral Blood CD34+ Cell Count before the second apheresis session
After the fifth G-CSF dose, immediately before the second apheresis session (11:30 ±15 minutes).
Peripheral Blood CD34+ Cell Count 12 Hours After the Fourth G-CSF Dose
12 (±1) hours after the fourth G-CSF dose, regardless of the timing of the first apheresis session.
G-CSF Dose Escalation
From the first apheresis session until completion of the final apheresis session, typically within 2 consecutive days and up to 3 consecutive days.
7.5 μg/kg subcutaneous once daily for 4-5 days at 08:00 ± 15 min
7.5 μg/kg subcutaneous once daily for 4-5 days at 20:00 ± 15 min
Subcutaneous recombinant human G-CSF (7.5 μg/kg once daily) administered for 4 consecutive days. Participants are assigned to a fixed dosing time: 08:00 (±15 minutes) or 20:00 (±15 minutes).
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
First Submitted
February 13, 2026
First Posted
February 20, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Primary Completion
March 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Individual participant data will not be shared because the study involves healthy donors and contains potentially identifiable information. De-identified, aggregate results will be reported in publications and presentations. Reasonable requests for additional information may be considered by the study team on a case-by-case basis, subject to ethics approval and data governance requirements.
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Source: ClinicalTrials.gov.
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