Granulocyte Colony-Stimulating Factor (G-CSF) MobilizationCHRONO-MOBILIZNCT07423728
CHRONO-MOBILIZE: Chronotherapy of G-CSF for CD34+ Mobilization in Healthy Donors
A study testing G-CSF (Granulocyte colony-stimulating factor) in people with Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization, run by First Affiliated Hospital of Zhejiang University at 3 sites in China.
Trial summary
Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization
- What is being tested?
- G-CSF (Granulocyte colony-stimulating factor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesChina
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55 years
- HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria
- Body weight ≥35 kg and adequate blood volume/BSA for apheresis
- Karnofsky score ≥80
- Screening labs meet thresholds (Hb/platelets/ANC, liver/renal/coagulation), no splenomegaly, pregnancy test negative if applicable
- Written informed consent
- Stable circadian rhythm before mobilization (no night shift/no ≥3 time-zone travel; avoid melatonin/sedatives or other agents affecting sleep/circadian rhythm)
Who cannot join
- Prior/current hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease)
- Significant cardiovascular/structural heart disease, uncontrolled hypertension, uncontrolled diabetes
- Neurologic/psychiatric disorders affecting adherence
- Sleep/circadian disorders; recent night shift or ≥3 time-zone travel
- Prohibited medications (e.g., beta-blockers, systemic steroids >10 mg prednisone-equivalent ≥7 days, melatonin/psychotropics; recent G-CSF/GM-CSF/CXCR4 inhibitor use)
- Severe allergy to G-CSF or components
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hengwei Wu, MD, 19858162455, wuhengwei@zju.edu.cn
Yanmin Zhao, MD, 057187236706
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wei Shi, MD, +86 027-83663337, shiwei076@hust.edu.cn
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Weijie Cao, MD, +86 0371-66278897, caoweijie2003@126.com
About this study
Official title: Effect of Different Administration Timing of G-CSF on Peripheral Blood CD34+ Cell Mobilization in Healthy Donors: A Prospective Multicenter Randomized Controlled Trial
Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies. This prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF once daily for 4-5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.
The study protocol was substantially amended following approval by the Institutional Review Board. The amendments included revisions to the G-CSF administration regimen, the primary and secondary outcome measures, and the assessment schedule. Enrollment under the revised protocol commenced on 1st Nov. Participants enrolled under the previous protocol version will be documented separately and will not be included in the prespecified primary analysis of the revised-protocol cohort.
Read the detailed description
Background and Rationale
Peripheral blood stem cell collection after G-CSF mobilization is the most widely used donation approach for allo-HSCT. Donor mobilization outcomes exhibit inter-individual variability, and donors with lower circulating CD34+ levels may require longer processing volumes, additional collection days, or rescue mobilization. Circadian biology may influence hematopoietic cell trafficking and cytokine responses, suggesting that the administration timing of G-CSF could affect mobilization intensity and collection efficiency. This trial tests whether a simple, operational change in dosing time can improve pre-apheresis CD34+ levels in healthy donors.
Study Design
This is a prospective, multicenter, stratified randomized controlled trial with two parallel arms. The study is open-label due to the nature of the intervention (fixed dosing times), while the statistician will remain blinded to group allocation until database lock. Allocation is stratified by donor age (<40 vs ≥40 years) and sex to balance key donor characteristics across arms.
Interventions and Procedures
Eligible healthy donors will receive subcutaneous G-CSF at 10 μg/kg once daily for 4-5 consecutive days (Day 1 to Day 5, according to the first day collection efficacy), assigned to one of the following schedules:
Morning group: 08:00 (±15 minutes) each day
Evening group: 20:00 (±15 minutes) each day
The first apheresis session is scheduled to begin after the forth G-CSF dose. Collection targets are based on recipient weight, with standard operational procedures for conducting a second collection day if the first-day yield does not meet the target. If peripheral blood CD34+ is low after the final G-CSF dose, centers may apply rescue mobilization per local practice, and such use will be recorded for sensitivity analyses.
Outcome Measures Primary Outcome: To compare peripheral blood CD34+ cell counts (cells/μL) between healthy donors receiving morning (08:00) versus evening (20:00) G-CSF administration, measured at a standardized clock time of 11:30 (±15 minutes), after the fourth G-CSF dose and immediately before the first apheresis session.
Sample Size and Analysis Overview A total of 160 donors (80 per group) will be enrolled to provide adequate power for detecting clinically meaningful differences in the primary endpoint while allowing for non-evaluable cases. The primary analysis will follow the intention-to-treat principle, with additional per-protocol and sensitivity analyses as appropriate, including analyses accounting for rescue mobilization when applicable.
Safety Monitoring and Follow-up Donors will be monitored with clinical assessment and routine laboratory testing during the mobilization period and on collection days. Adverse events commonly associated with G-CSF (e.g., bone pain) and donation-related events will be recorded and managed per standard-of-care practices. Donors will be followed through approximately Day 30 to capture delayed or persistent adverse events.
- Being tested
- G-CSF (Granulocyte colony-stimulating factor)
- Keywords
- CD34, G-CSF, Allo-HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF (Granulocyte colony-stimulating factor)Drug
Subcutaneous recombinant human G-CSF (7.5 μg/kg once daily) administered for 4 consecutive days. Participants are assigned to a fixed dosing time: 08:00 (±15 minutes) or 20:00 (±15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Morning G-CSF Dosing | Active comparator | 7.5 μg/kg subcutaneous once daily for 4-5 days at 08:00 ± 15 min Receives: Drug: G-CSF (Granulocyte colony-stimulating factor) |
| Evening G-CSF Dosing | Experimental | 7.5 μg/kg subcutaneous once daily for 4-5 days at 20:00 ± 15 min Receives: Drug: G-CSF (Granulocyte colony-stimulating factor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Blood CD34+ Cell Count before the first apheresis session
Peripheral blood CD34+ cell count (cells/μL) measured at a fixed clock time of 11:30 (±15 minutes), after the fourth G-CSF dose and immediately before the first apheresis session, scheduled to begin at 12:00 in both treatment groups. CD34+ cell counts will be determined using standardized flow cytometry procedures.
Measured: After the fourth G-CSF dose, immediately before the first apheresis session (11:30 ±15 minutes).
Secondary outcomes (11)
Peripheral Blood CD34+ Cell Count 12 Hours After the Third G-CSF Dose
Peripheral blood CD34+ cell count (cells/μL) measured 12 (±1) hours after the third G-CSF dose, before any apheresis procedure. CD34+ cells will be enumerated using standardized flow cytometry procedures.
Measured: 12 (±1) hours after the third G-CSF dose, before the first apheresis session.
CD34+ Cell Yield During the First Apheresis Session
Total number of CD34+ cells collected during the first apheresis session, normalized to donor body weight and expressed as ×10⁶ CD34+ cells/kg.
Measured: At completion of the first apheresis session following the fourth G-CSF dose.
Peripheral Blood CD34+ Cell Count before the second apheresis session
Peripheral blood CD34+ cell count (cells/μL) measured at a fixed clock time of 11:30 (±15 minutes), after the fifth G-CSF dose and immediately before the second apheresis session, scheduled to begin at 12:00 in both treatment groups. CD34+ cell counts will be determined using standardized flow cytometry procedures.
Measured: After the fifth G-CSF dose, immediately before the second apheresis session (11:30 ±15 minutes).
Peripheral Blood CD34+ Cell Count 12 Hours After the Fourth G-CSF Dose
Peripheral blood CD34+ cell count (cells/μL) measured 12 (±1) hours after the fourth G-CSF dose using standardized flow cytometry procedures.
Measured: 12 (±1) hours after the fourth G-CSF dose, regardless of the timing of the first apheresis session.
G-CSF Dose Escalation
Proportion of donors requiring an increase in the daily G-CSF dose above the protocol-specified 10 μg/kg/day because of inadequate mobilization or insufficient CD34+ cell yield. Routine administration of an additional fifth G-CSF dose without increasing the daily dose will not be classified as dose escalation.
Measured: From the first apheresis session until completion of the final apheresis session, typically within 2 consecutive days and up to 3 consecutive days.
Proportion of Donors Requiring Plerixafor Rescue Mobilization
Proportion of donors receiving plerixafor rescue mobilization because of inadequate peripheral blood CD34+ mobilization or insufficient collection yield, according to prespecified rescue criteria.
Measured: From the first G-CSF dose through completion of the final apheresis session, typically within 2 days and up to 3 consecutive days of apheresis.
Incidence of Adverse Events in Healthy Donors
Incidence and severity of adverse events associated with G-CSF mobilization, apheresis procedures, and rescue mobilization, including bone pain, headache, fatigue, citrate-related reactions, and vascular access complications. Adverse events will be assessed according to the protocol-specified grading system.
Measured: From the first G-CSF dose through 30 days after the final apheresis session.
Time to Neutrophil Engraftment After Transplantation
Time from stem cell infusion to neutrophil engraftment in transplant recipients, defined as the first of three consecutive days with an absolute neutrophil count ≥0.5 × 10⁹/L. Death before engraftment will be treated as a competing event in exploratory analyses.
Measured: From transplantation (Day 0) through Day 100 after transplantation.
Time to Platelet Engraftment After Transplantation
Time from stem cell infusion to platelet engraftment in transplant recipients, defined as the first of seven consecutive days with a platelet count ≥20 × 10⁹/L without platelet transfusion during the preceding seven days. Death before engraftment will be treated as a competing event.
Measured: From transplantation (Day 0) through Day 100 after transplantation.
Cumulative Incidence of De Novo Grade II-IV and III-IV Acute Graft-versus-Host Disease
Cumulative incidence of newly occurring grade II-IV and grade III-IV acute graft-versus-host disease (aGVHD) among transplant recipients, assessed using prespecified standard grading criteria. Competing events will be handled using competing-risk methods.
Measured: From transplantation (Day 0) through Day 100 after transplantation.
Total Number of Apheresis Sessions per Donor
Total number of apheresis sessions performed for each donor during the mobilization and collection period.
Measured: From the first apheresis session through completion of the final apheresis session, typically within 2 consecutive days and up to 3 consecutive days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulocyte Colony-Stimulating Factor (G-CSF) MobilizationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter, stratified, randomized parallel-group trial. Healthy donors are assigned 1:1 to morning vs evening once-daily G-CSF dosing (08:00±15 min vs 20:00±15 min) for 4 consecutive days. Randomization uses block randomization and is stratified by donor age (\<40 vs ≥40 years) and sex.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423728
- Sponsor's protocol ID
- ZJUFAH-CHRONOMOB
- Acronym
- CHRONO-MOBILIZ
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves healthy donors and contains potentially identifiable information. De-identified, aggregate results will be reported in publications and presentations. Reasonable requests for additional information may be considered by the study team on a case-by-case basis, subject to ethics approval and data governance requirements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Administration Timing of G-CSF on Peripheral Blood CD34+ Cell Mobilization in Healthy Donors: A Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07423728
- Acronym / sponsor ID
- CHRONO-MOBILIZ / ZJUFAH-CHRONOMOB
- Keywords
- CD34, G-CSF, Allo-HSCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Ruijin Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Feb 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.
Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies. This prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF once daily for 4-5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.
The study protocol was substantially amended following approval by the Institutional Review Board. The amendments included revisions to the G-CSF administration regimen, the primary and secondary outcome measures, and the assessment schedule. Enrollment under the revised protocol commenced on 1st Nov. Participants enrolled under the previous protocol version will be documented separately and will not be included in the prespecified primary analysis of the revised-protocol cohort.
Detailed description
Background and Rationale
Peripheral blood stem cell collection after G-CSF mobilization is the most widely used donation approach for allo-HSCT. Donor mobilization outcomes exhibit inter-individual variability, and donors with lower circulating CD34+ levels may require longer processing volumes, additional collection days, or rescue mobilization. Circadian biology may influence hematopoietic cell trafficking and cytokine responses, suggesting that the administration timing of G-CSF could affect mobilization intensity and collection efficiency. This trial tests whether a simple, operational change in dosing time can improve pre-apheresis CD34+ levels in healthy donors.
Study Design
This is a prospective, multicenter, stratified randomized controlled trial with two parallel arms. The study is open-label due to the nature of the intervention (fixed dosing times), while the statistician will remain blinded to group allocation until database lock. Allocation is stratified by donor age (<40 vs ≥40 years) and sex to balance key donor characteristics across arms.
Interventions and Procedures
Eligible healthy donors will receive subcutaneous G-CSF at 10 μg/kg once daily for 4-5 consecutive days (Day 1 to Day 5, according to the first day collection efficacy), assigned to one of the following schedules:
Morning group: 08:00 (±15 minutes) each day
Evening group: 20:00 (±15 minutes) each day
The first apheresis session is scheduled to begin after the forth G-CSF dose. Collection targets are based on recipient weight, with standard operational procedures for conducting a second collection day if the first-day yield does not meet the target. If peripheral blood CD34+ is low after the final G-CSF dose, centers may apply rescue mobilization per local practice, and such use will be recorded for sensitivity analyses.
Outcome Measures Primary Outcome: To compare peripheral blood CD34+ cell counts (cells/μL) between healthy donors receiving morning (08:00) versus evening (20:00) G-CSF administration, measured at a standardized clock time of 11:30 (±15 minutes), after the fourth G-CSF dose and immediately before the first apheresis session.
Sample Size and Analysis Overview A total of 160 donors (80 per group) will be enrolled to provide adequate power for detecting clinically meaningful differences in the primary endpoint while allowing for non-evaluable cases. The primary analysis will follow the intention-to-treat principle, with additional per-protocol and sensitivity analyses as appropriate, including analyses accounting for rescue mobilization when applicable.
Safety Monitoring and Follow-up Donors will be monitored with clinical assessment and routine laboratory testing during the mobilization period and on collection days. Adverse events commonly associated with G-CSF (e.g., bone pain) and donation-related events will be recorded and managed per standard-of-care practices. Donors will be followed through approximately Day 30 to capture delayed or persistent adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, stratified, randomized parallel-group trial. Healthy donors are assigned 1:1 to morning vs evening once-daily G-CSF dosing (08:00±15 min vs 20:00±15 min) for 4 consecutive days. Randomization uses block randomization and is stratified by donor age (<40 vs ≥40 years) and sex.
| Arm | Type | Receives |
|---|---|---|
| Morning G-CSF Dosing | Active comparator | Drug: G-CSF (Granulocyte colony-stimulating factor)7.5 μg/kg subcutaneous once daily for 4-5 days at 08:00 ± 15 min |
| Evening G-CSF Dosing | Experimental | Drug: G-CSF (Granulocyte colony-stimulating factor)7.5 μg/kg subcutaneous once daily for 4-5 days at 20:00 ± 15 min |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-55 years
- HLA matching appropriate for intended allo-HSCT recipient and meets donor medical evaluation criteria
- Body weight ≥35 kg and adequate blood volume/BSA for apheresis
- Karnofsky score ≥80
- Screening labs meet thresholds (Hb/platelets/ANC, liver/renal/coagulation), no splenomegaly, pregnancy test negative if applicable
Key exclusion criteria (6 listed)
- Prior/current hematologic or immune diseases (e.g., aplastic anemia, leukemia, lymphoma, autoimmune disease)
- Significant cardiovascular/structural heart disease, uncontrolled hypertension, uncontrolled diabetes
- Neurologic/psychiatric disorders affecting adherence
- Sleep/circadian disorders; recent night shift or ≥3 time-zone travel
- Prohibited medications (e.g., beta-blockers, systemic steroids >10 mg prednisone-equivalent ≥7 days, melatonin/psychotropics; recent G-CSF/GM-CSF/CXCR4 inhibitor use)
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 |
|---|---|---|
| G-CSF (Granulocyte colony-stimulating factor)Subcutaneous recombinant human G-CSF (7.5 μg/kg once daily) administered for 4 consecutive days. Participants are assigned to a fixed dosing time: 08:00 (±15 minutes) or 20:00 (±15 minutes). | Drug | Evening G-CSF Dosing, Morning G-CSF Dosing |
Primary outcome
Peripheral Blood CD34+ Cell Count before the first apheresis session
Time frame: After the fourth G-CSF dose, immediately before the first apheresis session (11:30 ±15 minutes).
Peripheral blood CD34+ cell count (cells/μL) measured at a fixed clock time of 11:30 (±15 minutes), after the fourth G-CSF dose and immediately before the first apheresis session, scheduled to begin at 12:00 in both treatment groups. CD34+ cell counts will be determined using standardized flow cytometry procedures.
11 secondary outcomes
Peripheral Blood CD34+ Cell Count 12 Hours After the Third G-CSF Dose
Time frame: 12 (±1) hours after the third G-CSF dose, before the first apheresis session.
CD34+ Cell Yield During the First Apheresis Session
Time frame: At completion of the first apheresis session following the fourth G-CSF dose.
Peripheral Blood CD34+ Cell Count before the second apheresis session
Time frame: After the fifth G-CSF dose, immediately before the second apheresis session (11:30 ±15 minutes).
Peripheral Blood CD34+ Cell Count 12 Hours After the Fourth G-CSF Dose
Time frame: 12 (±1) hours after the fourth G-CSF dose, regardless of the timing of the first apheresis session.
G-CSF Dose Escalation
Time frame: From the first apheresis session until completion of the final apheresis session, typically within 2 consecutive days and up to 3 consecutive days.
Proportion of Donors Requiring Plerixafor Rescue Mobilization
Time frame: From the first G-CSF dose through completion of the final apheresis session, typically within 2 days and up to 3 consecutive days of apheresis.
Incidence of Adverse Events in Healthy Donors
Time frame: From the first G-CSF dose through 30 days after the final apheresis session.
Time to Neutrophil Engraftment After Transplantation
Time frame: From transplantation (Day 0) through Day 100 after transplantation.
Time to Platelet Engraftment After Transplantation
Time frame: From transplantation (Day 0) through Day 100 after transplantation.
Cumulative Incidence of De Novo Grade II-IV and III-IV Acute Graft-versus-Host Disease
Time frame: From transplantation (Day 0) through Day 100 after transplantation.
Total Number of Apheresis Sessions per Donor
Time frame: From the first apheresis session through completion of the final apheresis session, typically within 2 consecutive days and up to 3 consecutive days.
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 29 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves healthy donors and contains potentially identifiable information. De-identified, aggregate results will be reported in publications and presentations. Reasonable requests for additional information may be considered by the study team on a case-by-case basis, subject to ethics approval and data governance requirements.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-CSF (Granulocyte colony-stimulating factor) in people with Granulocyte Colony-Stimulating Factor (G-CSF) Mobilization, run by First Affiliated Hospital of Zhejiang University at 3 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 7 inclusion and 6 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 Hengwei Wu, MD (+8619858162455, cctv3194495@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Blood CD34+ Cell Count before the first apheresis session (time frame: After the fourth G-CSF dose, immediately before the first apheresis session (11:30 ±15 minutes).). 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 29 Oct 2026.