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

Recruiting now · Not applicable

Conditions studied: Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization

In brief

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.

Key facts

Study ID

NCT07423728

Run by

First Affiliated Hospital of Zhejiang University

People needed

160

Starts

2026-03-01

Expected to finish

2027-03-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Screening labs meet thresholds (Hb/platelets/ANC, liver/renal/coagulation), no splenomegaly, pregnancy test negative if applicable
• Written informed consent
• Stable circadian rhythm before mobilization (no night shift/no ≥3 time-zone travel; avoid melatonin/sedatives or other agents affecting sleep/circadian rhythm)

You may not qualify if…

• 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
• Prohibited medications (e.g., beta-blockers, systemic steroids >10 mg prednisone-equivalent ≥7 days, melatonin/psychotropics; recent G-CSF/GM-CSF/CXCR4 inhibitor use)
• Severe allergy to G-CSF or components

Where it is running

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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