이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 7월 13일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

560

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Hunan
      • Changsha, Hunan, 중국
        • 모병
        • Xiangya Hospital of Central South University
        • 연락하다:
    • Zhejiang
      • Hangzhou, Zhejiang, 중국
        • 모병
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • 연락하다:
      • Hangzhou, Zhejiang, 중국
        • 모병
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
        • 연락하다:
      • Hangzhou, Zhejiang, 중국
        • 모병
        • The First Affiliated Hospital, Zhejiang University School of Medicine.
        • 연락하다:
      • Jinhua, Zhejiang, 중국
        • 모병
        • Jinhua Central Hospital
        • 연락하다:
      • Ningbo, Zhejiang, 중국
        • 모병
        • The first affiliated hospital of Ningbo university
        • 연락하다:
      • Ningbo, Zhejiang, 중국
        • 모병
        • The Affiliated People's Hospital of Ningbo University
        • 연락하다:
      • Wenzhou, Zhejiang, 중국
        • 모병
        • The First Affiliated Hospital of Wenzhou Medical University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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).
의약품: 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)
활성 비교기: 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).
의약품: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
기간: 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.
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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;
기간: 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;
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

First Affiliated Hospital of Zhejiang University

협력자

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

수사관

  • 수석 연구원: YI LUO, Zhejiang University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 10일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2029년 7월 10일

연구 등록 날짜

최초 제출

2026년 7월 4일

QC 기준을 충족하는 최초 제출

2026년 7월 4일

처음 게시됨 (실제)

2026년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ZJU-GCSF

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Healthy Hematopoietic Stem Cell Donor에 대한 임상 시험

Divided-dose Granulocyte colony-stimulating factor (G-CSF)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Burundi

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다