Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors

NCT07692841 | Recruiting Phase 3 DMC

• 1 other identifier: ZJU-GCSF
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 8

Brief Summary

National and international guidelines/consensus recommend G-CSF (granulocyte colony-stimulating factor) at 10 μg/kg/day as a single daily dose or divided into two daily doses for mobilization in healthy donors for allogeneic hematopoietic stem cell transplantation. However, there is no consensus or standard regarding single versus divided dosing, and high-quality evidence is lacking. Existing randomized controlled trials have small sample sizes and inconsistent conclusions, and none have focused on Asian population characteristics (e.g., body weight and drug metabolism differences). This study aims to provide level I evidence to optimize donor experience and define the optimal administration strategy. Inclusion criteria: Healthy allogeneic stem cell donors aged 18-60 years, meeting institutional standard donor screening criteria (HLA matching, normal blood counts, normal liver and kidney function, negative infection screening), and providing written informed consent. Primary endpoint: The rate of achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor body weight) after 5 days of G-CSF mobilization. Secondary endpoints: The rate of achieving ≥ 2 × 10⁶ CD34⁺ cells/kg with at most one apheresis; time to myeloid, platelet, and erythroid engraftment in recipients; the proportion and composition of immune cells (CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product; donor adverse events; donor-reported outcomes; and the difference in CD34⁺ stem cell yields between single-dose and divided-dose mobilization. Intervention: G-CSF will be administered at a total dose of 10 μg/kg/day, either as a single daily injection or divided into two equal daily injections. This study is designed to investigate whether single-dose or divided-dose G-CSF administration is superior for mobilizing healthy donors in allogeneic hematopoietic stem cell transplantation.

Conditions

Healthy Hematopoietic Stem Cell Donor; Healthy Allogeneic Hematopoietic Stem Cell Donor

Keywords

healthy allogeneic hematopoietic stem cell donor; granulocyte colony-stimulating factor (G-CSF); allogeneic hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).

  Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).

  From enrollment to the end of stem cell collection (8 weeks)

Secondary Outcomes (11)

• Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.

  From enrollment to the end of stem cell collection (8 weeks)

• Cumulative incidence rates of neutrophil engraftment in allogeneic stem cell transplant recipients.

  28 days after transplantation

• Cumulative incidence rates of platelet engraftment in allogeneic stem cell transplant recipients.

  28 days after transplantation

• Cumulative incidence rates of erythroid engraftment in allogeneic stem cell transplant recipients.

  28 days after transplantation

• The proportion and composition of immune cells (including CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product

  From enrollment to the end of stem cell collection (8 weeks)

Study Arms (2)

Divided-dose Arm

EXPERIMENTAL

G-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed).

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

Single-dose Arm

ACTIVE COMPARATOR

G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).

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

Interventions

Divided-dose Granulocyte colony-stimulating factor (G-CSF) DRUG

G-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed)

Divided-dose Arm

Single-dose Granulocyte colony-stimulating factor (G-CSF) DRUG

G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).

Single-dose Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years.
• Provision of written informed consent.
• White blood cell (WBC) count \> 2.5 × 10⁹/L.
• Absolute neutrophil count (ANC) \> 1.5 × 10⁹/L and platelet count \> 100 × 10⁹/L.
• Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching.
• Body weight ≥ 40 kg for females and ≥ 45 kg for males.

You may not qualify if:

• Currently having any disease or condition that, in the judgment of the investigator, would make the donor unsuitable for participation in this study, such as severe neurological, hepatic, renal, endocrine, cardiovascular, hematologic, gastrointestinal, respiratory, or metabolic diseases; malignancies; myeloproliferative disorders; or psychiatric illnesses.
• Currently having an active infection requiring systemic therapy.
• Allergy to the study drug.
• Presence of a malignant tumor.
• Untreated HBV infection with HBV-DNA above the lower limit of detection.
• HIV infection.
• Addition of any new medication within 2 weeks prior to entry into this study.
• Female donors who are pregnant or breastfeeding.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• First Affiliated Hospital of Ningbo University: collaborator
• Jinhua Central Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• The Affiliated People's Hospital of Ningbo University: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (8)

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine.

Hangzhou, Zhejiang, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, China

RECRUITING

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 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

Study Officials

• YI LUO

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YIBO Wu

CONTACT

+8657187233801; wuyibo7@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 9, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 10, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: IPD will be made available upon reasonable request to the principal investigator, after the primary results are published, via a secure data repository (e.g., Zenodo or institutional data archive).
• Access Criteria: IPD will be made available upon reasonable request to the principal investigator, after the primary results are published, via a secure data repository (e.g., Zenodo or institutional data archive). A data dictionary and study protocol will be provided alongside the data. Access will be granted for pre-specified research purposes only, and requestors must sign a data access agreement.

Locations

CN (8)