CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age 18-55 years
HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria
Body weight ≥35 kg and adequate blood volume/BSA for apheresis
Karnofsky score ≥80
Disqualifiers
Prior/current hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease)
Significant cardiovascular/structural heart disease, uncontrolled hypertension, uncontrolled diabetes
Neurologic/psychiatric disorders affecting adherence
Sleep/circadian disorders; recent night shift or ≥3 time-zone travel
Trial design
Design model
Parallel
Treatments tested in this trial
G-CSF (Granulocyte colony-stimulating factor)
DrugSubcutaneous 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Morning G-CSF DosingActive comparator 1 intervention
Group B: Evening G-CSF DosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pre-Apheresis Peripheral Blood CD34+ Cell Count
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.
Time frame
On the day of first apheresis: approximately 12 (±1) hours after the final G-CSF dose and within 60 minutes prior to apheresis start.Sponsors and contacts
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First Affiliated Hospital of Zhejiang University
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Tongji Hospital
Collaborator
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov