Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Single-dose Granulocyte colony-stimulating factor (G-CSF)
DrugG-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)
DrugG-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed)
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: Divided-dose ArmExperimental treatment 1 intervention
Group B: Single-dose ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment to the end of stem cell collection (8 weeks)Secondary outcomes
1
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.
Time frame
From enrollment to the end of stem cell collection (8 weeks)2
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.
Time frame
28 days after transplantation3
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.
Time frame
28 days after transplantation4
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.
Time frame
28 days after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Zhejiang University
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
The Affiliated People's Hospital of Ningbo University
Collaborator
Jinhua Central Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Source ClinicalTrials.gov