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

4. juli 2026 opdateret af: Yi Luo, First Affiliated Hospital of Zhejiang University

Randomized Controlled Trial Comparing Single-dose and Divided-dose G-CSF for Peripheral Blood Stem Cell Mobilization in Healthy Donors for Allogeneic Hematopoietic Stem Cell Transplantation.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Weight-based mobilization: G-CSF 10 μg/kg/day × 5 days, SC, once daily or in two divided doses (max 7 days). Apheresis begins on day 5; subsequent dosing and collections are guided by the CD34⁺ yield, not to exceed 7 days.

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

560

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Hunan
      • Changsha, Hunan, Kina
        • Xiangya Hospital of Central South University
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Kontakt:
      • Hangzhou, Zhejiang, Kina
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • Kontakt:
      • Hangzhou, Zhejiang, Kina
        • The First Affiliated Hospital, Zhejiang University School of Medicine.
        • Kontakt:
      • Jinhua, Zhejiang, Kina
        • Jinhua Central Hospital
        • Kontakt:
      • Ningbo, Zhejiang, Kina
        • The Affiliated People's Hospital of Ningbo University
        • Kontakt:
      • Ningbo, Zhejiang, Kina
        • The First Affiliated Hospital of Ningbo University
        • Kontakt:
      • Wenzhou, Zhejiang, Kina
        • The First Affiliated Hospital of Wenzhou Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Currently having an active infection requiring systemic therapy.
  3. Allergy to the study drug.
  4. Presence of a malignant tumor.
  5. Untreated HBV infection with HBV-DNA above the lower limit of detection.
  6. HIV infection.
  7. Addition of any new medication within 2 weeks prior to entry into this study.
  8. Female donors who are pregnant or breastfeeding.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Divided-dose Arm
G-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed).
Medicin: Divided-dose Granulocyte colony-stimulating factor (G-CSF)
G-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed)
Aktiv komparator: Single-dose Arm
G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).
Medicin: Single-dose Granulocyte colony-stimulating factor (G-CSF)
G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
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.
Tidsramme: 28 days after transplantation
Defined as time from stem cell infusion to the first of three consecutive days with ANC ≥ 0.5 × 10⁹/L.
28 days after transplantation
Cumulative incidence rates of platelet engraftment in allogeneic stem cell transplant recipients.
Tidsramme: 28 days after transplantation
Proportion of recipients achieving platelet count ≥ 20 × 10⁹/L with no platelet transfusion for at least 7 consecutive days, by Day +28 post-transplant.
28 days after transplantation
Cumulative incidence rates of erythroid engraftment in allogeneic stem cell transplant recipients.
Tidsramme: 28 days after transplantation
Proportion of recipients achieving hemoglobin ≥ 60 g/L without red blood cell transfusion for at least 7 consecutive days, by Day +28 post-transplant.
28 days after transplantation
The proportion and composition of immune cells (including CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
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)
Donor adverse events and recipient-reported outcomes
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
Donor adverse events and recipient-reported outcomes
From enrollment to the end of stem cell collection (8 weeks)
Comparison of peripheral blood CD34⁺ cell counts (cells/μL) on Days 1, 2, 3, 4, and 5 between healthy donors mobilized with single-dose versus divided-dose G-CSF
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
Comparison of peripheral blood CD34⁺ cell counts (cells/μL) on Days 1, 2, 3, 4, and 5 between healthy donors mobilized with single-dose versus divided-dose G-CSF
From enrollment to the end of stem cell collection (8 weeks)
Comparison of the rate of engraftment failure in recipients between the two groups
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
Comparison of the rate of engraftment failure in recipients between the two groups
From enrollment to the end of stem cell collection (8 weeks)
Comparison of overall survival (OS) rates at 2 years in recipients between the two groups;
Tidsramme: 2 years post transplantation
Comparison of overall survival (OS) rates at 2 years in recipients between the two groups;
2 years post transplantation
Comparison of overall survival (OS) rates at 5 years in recipients between the two groups;
Tidsramme: 5 years post transplantation
Comparison of overall survival (OS) rates at 5 years in recipients between the two groups;
5 years post transplantation
Comparison of CD34⁺ stem cell yield in the apheresis product between the two groups
Tidsramme: From enrollment to the end of stem cell collection (8 weeks)
Comparison of CD34⁺ stem cell yield in the apheresis product between the two groups
From enrollment to the end of stem cell collection (8 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital of Zhejiang University

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: YI LUO, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

10. juli 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

10. juli 2029

Datoer for studieregistrering

Først indsendt

4. juli 2026

Først indsendt, der opfyldte QC-kriterier

4. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZJU-GCSF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

We plan to share de-identified individual participant data (IPD) collected throughout the trial, including baseline donor characteristics, daily peripheral blood CD34⁺ cell counts, apheresis product immune cell subsets, donor adverse events, recipient engraftment times, engraftment rates, and overall survival data at 2 and 5 years. 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 will be granted for pre-specified research purposes only, and requestors must sign a data access agreement.

IPD-delingstidsramme

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).

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

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Kliniske forsøg med Divided-dose Granulocyte colony-stimulating factor (G-CSF)

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