Healthy Hematopoietic Stem Cell DonorPhase 3NCT07692841
Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
A Phase 3 study testing Single-dose Granulocyte colony-stimulating factor (G-CSF) and Divided-dose Granulocyte colony-stimulating factor (G-CSF) in people with Healthy Hematopoietic Stem Cell Donor and Healthy Allogeneic Hematopoietic Stem Cell Donor, run by First Affiliated Hospital of Zhejiang University at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy Hematopoietic Stem Cell Donor, Healthy Allogeneic Hematopoietic Stem Cell Donor
- What is being tested?
- Single-dose Granulocyte colony-stimulating factor (G-CSF) and Divided-dose Granulocyte colony-stimulating factor (G-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 8 sitesChina
- Study dates
- 10 Jul 2026to 10 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Yajing Xu, +8657187233801, xyyajingxu@csu.edu.cn
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Haowen Xiao, +8657187233801, haowenxiaoxiao@zju.edu.cn
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine.
Hangzhou, Zhejiang
YIBO WU, +8657187233801, wuyibo7@126.com
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yang XU, +8657187233801, yxu@zju.edu.cn
- Recruiting
Jinhua Central Hospital
Jinhua, Zhejiang
Lihong Ni, +8657187233801, nilihongwy@163.com
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang
Ying Lu, +8657187233801, rmluying@nbu.edu.cn
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Lieguang Chen, +8657187233801, fyychenlieguang@nbu.edu.cn
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Yi Chen, +8657187233801, chenyi19527@163.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Being tested
- Single-dose Granulocyte colony-stimulating factor (G-CSF), Divided-dose Granulocyte colony-stimulating factor (G-CSF)
- Keywords
- healthy allogeneic hematopoietic stem cell donor, granulocyte colony-stimulating factor (G-CSF), allogeneic hematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Single-dose Granulocyte colony-stimulating factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
Measured: From enrollment to the end of stem cell collection (8 weeks)
Cumulative incidence rates of neutrophil engraftment in allogeneic stem cell transplant recipients.
Defined as time from stem cell infusion to the first of three consecutive days with ANC ≥ 0.5 × 10⁹/L.
Measured: 28 days after transplantation
Cumulative incidence rates of platelet engraftment in allogeneic stem cell transplant recipients.
Proportion of recipients achieving platelet count ≥ 20 × 10⁹/L with no platelet transfusion for at least 7 consecutive days, by Day +28 post-transplant.
Measured: 28 days after transplantation
Cumulative incidence rates of erythroid engraftment in allogeneic stem cell transplant recipients.
Proportion of recipients achieving hemoglobin ≥ 60 g/L without red blood cell transfusion for at least 7 consecutive days, by Day +28 post-transplant.
Measured: 28 days after transplantation
The proportion and composition of immune cells (including CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product
The proportion and composition of immune cells (including CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product
Measured: From enrollment to the end of stem cell collection (8 weeks)
Donor adverse events and recipient-reported outcomes
Donor adverse events and recipient-reported outcomes
Measured: 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
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
Measured: From enrollment to the end of stem cell collection (8 weeks)
Comparison of the rate of engraftment failure in recipients between the two groups
Comparison of the rate of engraftment failure in recipients between the two groups
Measured: 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;
Comparison of overall survival (OS) rates at 2 years in recipients between the two groups;
Measured: 2 years post transplantation
Comparison of overall survival (OS) rates at 5 years in recipients between the two groups;
Comparison of overall survival (OS) rates at 5 years in recipients between the two groups;
Measured: 5 years post transplantation
Comparison of CD34⁺ stem cell yield in the apheresis product between the two groups
Comparison of CD34⁺ stem cell yield in the apheresis product between the two groups
Measured: From enrollment to the end of stem cell collection (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion10 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Hematopoietic Stem Cell DonorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Ningbo University, The Affiliated People's Hospital of Ningbo University, Jinhua Central Hospital, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Yi Luo, First Affiliated Hospital of Zhejiang University
- Investigators
- YI LUO, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692841
- Sponsor's protocol ID
- ZJU-GCSF
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07692841
- Acronym / sponsor ID
- ZJU-GCSF
- Keywords
- healthy allogeneic hematopoietic stem cell donor, granulocyte colony-stimulating factor (G-CSF), allogeneic hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Sir Run Run Shaw Hospital, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Ningbo University, The Affiliated People's Hospital of Ningbo University, Jinhua Central Hospital, Xiangya Hospital of Central South University
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 10 Jul 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divided-dose Arm | Experimental | Drug: 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). |
| Single-dose Arm | Active comparator | Drug: 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Single-dose Arm |
| 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) | Drug | Divided-dose Arm |
Primary outcome
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).
Time frame: 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).
11 secondary outcomes
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
Time frame: From enrollment to the end of stem cell collection (8 weeks)
Cumulative incidence rates of neutrophil engraftment in allogeneic stem cell transplant recipients.
Time frame: 28 days after transplantation
Cumulative incidence rates of platelet engraftment in allogeneic stem cell transplant recipients.
Time frame: 28 days after transplantation
Cumulative incidence rates of erythroid engraftment in allogeneic stem cell transplant recipients.
Time frame: 28 days after transplantation
The proportion and composition of immune cells (including CD34⁺, CD3⁺, CD19⁺, CD56⁺, etc.) in the apheresis product
Time frame: From enrollment to the end of stem cell collection (8 weeks)
Donor adverse events and recipient-reported outcomes
Time frame: 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
Time frame: From enrollment to the end of stem cell collection (8 weeks)
Comparison of the rate of engraftment failure in recipients between the two groups
Time frame: 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;
Time frame: 2 years post transplantation
Comparison of overall survival (OS) rates at 5 years in recipients between the two groups;
Time frame: 5 years post transplantation
Comparison of CD34⁺ stem cell yield in the apheresis product between the two groups
Time frame: From enrollment to the end of stem cell collection (8 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
YI LUO principal investigator
First Affiliated Hospital of Zhejiang University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-dose Granulocyte colony-stimulating factor (G-CSF) and Divided-dose Granulocyte colony-stimulating factor (G-CSF) in people with Healthy Hematopoietic Stem Cell Donor and Healthy Allogeneic Hematopoietic Stem Cell Donor, run by First Affiliated Hospital of Zhejiang University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YIBO Wu (+8657187233801, wuyibo7@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight). (time frame: From enrollment to the end of stem cell collection (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.