Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
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.
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: YIBO WU
- Telefonnummer: +8657187233801
- E-post: wuyibo7@126.com
Studiesteder
-
-
Hunan
-
Changsha, Hunan, Kina
- Rekruttering
- Xiangya Hospital of Central South University
-
Ta kontakt med:
- Yajing Xu
- Telefonnummer: +8657187233801
- E-post: xyyajingxu@csu.edu.cn
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Rekruttering
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Ta kontakt med:
- Yang Xu
- Telefonnummer: +8657187233801
- E-post: yxu@zju.edu.cn
-
Hangzhou, Zhejiang, Kina
- Rekruttering
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Ta kontakt med:
- Haowen Xiao
- Telefonnummer: +8657187233801
- E-post: haowenxiaoxiao@zju.edu.cn
-
Hangzhou, Zhejiang, Kina
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicine.
-
Ta kontakt med:
- YIBO WU
- Telefonnummer: +8657187233801
- E-post: wuyibo7@126.com
-
Jinhua, Zhejiang, Kina
- Rekruttering
- Jinhua Central Hospital
-
Ta kontakt med:
- Lihong Ni
- Telefonnummer: +8657187233801
- E-post: nilihongwy@163.com
-
Ningbo, Zhejiang, Kina
- Rekruttering
- The First Affiliated Hospital of Ningbo University
-
Ta kontakt med:
- Lieguang Chen
- Telefonnummer: +8657187233801
- E-post: fyychenlieguang@nbu.edu.cn
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Ningbo, Zhejiang, Kina
- Rekruttering
- The affiliated people's hospital of ningbo university
-
Ta kontakt med:
- Ying Lu
- Telefonnummer: +8657187233801
- E-post: rmluying@nbu.edu.cn
-
Wenzhou, Zhejiang, Kina
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
-
Ta kontakt med:
- Yi Chen
- Telefonnummer: +8657187233801
- E-post: chenyi19527@163.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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).
|
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).
|
G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: YI LUO, Zhejiang University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZJU-GCSF
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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