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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Pre-Apheresis Peripheral Blood CD34+ Cell Count — On the day of first apheresis: approximately 12 (±1) hours after the final G-CSF dose and within 60 minutes prior to apheresis start.
  Peripheral blood CD34+ cell count (cells/µL) measured by flow cytometry (ISHAGE single-platform method). Blood is drawn approximately 12 (±1) hours after the last G-CSF dose and within 60 minutes before the start of the first apheresis session.

Trial sites (3)

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