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

2026年7月13日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

560

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Hunan
      • Changsha、Hunan、中国
        • 招聘中
        • Xiangya Hospital of Central South University
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • 接触：
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • 接触：
      • Hangzhou、Zhejiang、中国
        • 招聘中
        • The First Affiliated Hospital, Zhejiang University School of Medicine.
        • 接触：
      • Jinhua、Zhejiang、中国
        • 招聘中
        • Jinhua Central Hospital
        • 接触：
      • Ningbo、Zhejiang、中国
        • 招聘中
        • The First Affiliated Hospital of Ningbo University
        • 接触：
      • Ningbo、Zhejiang、中国
        • 招聘中
        • The affiliated people's hospital of ningbo university
        • 接触：
      • Wenzhou、Zhejiang、中国
        • 招聘中
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
药品：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)
有源比较器：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).
药品：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
大体时间：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.
大体时间：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.
大体时间：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.
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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;
大体时间：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;
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital of Zhejiang University

合作者

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

调查人员

  • 首席研究员：YI LUO、Zhejiang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月10日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年7月10日

研究注册日期

首次提交

2026年7月4日

首先提交符合 QC 标准的

2026年7月4日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ZJU-GCSF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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