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

NCT07423728 | Recruiting DMC

• 1 other identifier: ZJUFAH-CHRONOMOB
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

CD34; G-CSF; Allo-HSCT

Outcome Measures

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.

  On the day of first apheresis: approximately 12 (±1) hours after the final G-CSF dose and within 60 minutes prior to apheresis start.

Study Arms (2)

Morning G-CSF Dosing

ACTIVE COMPARATOR

10 μg/kg subcutaneous once daily for 5 days at 08:00 ± 15 min

Drug: G-CSF (Granulocyte colony-stimulating factor)

Evening G-CSF Dosing

EXPERIMENTAL

10 μg/kg subcutaneous once daily for 5 days at 20:00 ± 15 min

Drug: G-CSF (Granulocyte colony-stimulating factor)

Interventions

G-CSF (Granulocyte colony-stimulating factor) DRUG

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.

Evening G-CSF Dosing; Morning G-CSF Dosing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Tongji Hospital: collaborator
• Ruijin Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (3)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Central Study Contacts

Hengwei Wu, MD

CONTACT

+8619858162455; cctv3194495@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This is a multicenter, stratified, randomized parallel-group trial. Healthy donors are assigned 1:1 to morning vs evening once-daily G-CSF dosing (08:00±15 min vs 20:00±15 min) for 5 consecutive days. Randomization uses centralized IWRS with block randomization and is stratified by donor age (\<40 vs ≥40 years) and sex. The study is open-label due to fixed dosing times; the primary endpoint is assessed at a standardized time point (≈12±1 h after the last dose and within 60 min before first apheresis).

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)