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CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors

NCT07423728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-06-29

No results posted yet for this study

Summary

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 prior to apheresis in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF 10 μg/kg once daily for 5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The primary endpoint is the peripheral blood CD34+ cell count measured approximately 12 hours after the last G-CSF dose and within 60 minutes before the start of the first apheresis session. Secondary endpoints include collection efficiency and CD34+ yield metrics, the proportion of donors achieving the target CD34+ dose on the first collection day, the need for a second collection day, and donor safety outcomes.

The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.

Conditions

  • Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization

Interventions

DRUG

G-CSF (Granulocyte colony-stimulating factor)

Subcutaneous recombinant human G-CSF (10 μg/kg once daily) administered for 5 consecutive days. Participants are assigned to a fixed dosing time: 08:00 (±15 minutes) or 20:00 (±15 minutes). Peripheral blood CD34+ is measured approximately 12 (±1) hours after the last dose and within 60 minutes before the first apheresis. The first apheresis begins \~12 (±1) hours after the final G-CSF dose. A second collection day may be performed per standard practice if the first-day yield does not meet the target; rescue mobilization (e.g., plerixafor) may be used per center practice when pre-defined low CD34+ criteria are met and will be recorded.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-03-01
Completion
2027-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07423728 on ClinicalTrials.gov