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

RecruitingNAAges 18 Years - 55 YearsAllFirst Affiliated Hospital of Zhejiang University
NCT07423728 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-55 years 2. HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria 3. Body weight ≥35 kg and adequate blood volume/BSA for apheresis 4. Karnofsky score ≥80 5. Screening labs meet thresholds (Hb/platelets/ANC, liver/renal/coagulation), no splenomegaly, pregnancy test negative if applicable 6. Written informed consent 7. Stable circadian rhythm before mobilization (no night shift/no ≥3 time-zone travel; avoid melatonin/sedatives or other agents affecting sleep/circadian rhythm) Exclusion Criteria: 1. Prior/current hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease) 2. Significant cardiovascular/structural heart disease, uncontrolled hypertension, uncontrolled diabetes 3. Neurologic/psychiatric disorders affecting adherence 4. Sleep/circadian disorders; recent night shift or ≥3 time-zone travel 5. Prohibited medications (e.g., beta-blockers, systemic steroids \>10 mg prednisone-equivalent ≥7 days, melatonin/psychotropics; recent G-CSF/GM-CSF/CXCR4 inhibitor use) 6. Severe allergy to G-CSF or components
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What it tests

  • G-CSF (Granulocyte colony-stimulating factor)
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Where

3 sites
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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