Single-Dose vs. Divided-Dose G-CSF for Stem Cell Mobilization in Healthy Allogeneic Donors
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：YIBO WU
- 電話番号：+8657187233801
- メール：wuyibo7@126.com
研究場所
-
-
Hunan
-
Changsha、Hunan、中国
- 募集
- Xiangya Hospital of Central South University
-
コンタクト：
- Yajing Xu
- 電話番号：+8657187233801
- メール：xyyajingxu@csu.edu.cn
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-
Zhejiang
-
Hangzhou、Zhejiang、中国
- 募集
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
コンタクト：
- Yang Xu
- 電話番号：+8657187233801
- メール：yxu@zju.edu.cn
-
Hangzhou、Zhejiang、中国
- 募集
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
コンタクト：
- Haowen Xiao
- 電話番号：+8657187233801
- メール：haowenxiaoxiao@zju.edu.cn
-
Hangzhou、Zhejiang、中国
- 募集
- The First Affiliated Hospital, Zhejiang University School of Medicine.
-
コンタクト：
- YIBO WU
- 電話番号：+8657187233801
- メール：wuyibo7@126.com
-
Jinhua、Zhejiang、中国
- 募集
- Jinhua Central Hospital
-
コンタクト：
- Lihong Ni
- 電話番号：+8657187233801
- メール：nilihongwy@163.com
-
Ningbo、Zhejiang、中国
- 募集
- The First Affiliated Hospital of Ningbo University
-
コンタクト：
- Lieguang Chen
- 電話番号：+8657187233801
- メール：fyychenlieguang@nbu.edu.cn
-
Ningbo、Zhejiang、中国
- 募集
- The affiliated people's hospital of ningbo university
-
コンタクト：
- Ying Lu
- 電話番号：+8657187233801
- メール：rmluying@nbu.edu.cn
-
Wenzhou、Zhejiang、中国
- 募集
- The First Affiliated Hospital of Wenzhou Medical University
-
コンタクト：
- Yi Chen
- 電話番号：+8657187233801
- メール：chenyi19527@163.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
G-CSF 10 μg/kg per day divided into two equal subcutaneous doses daily for 5 days (up to 7 days if needed)
|
|
アクティブコンパレータ：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).
|
G-CSF 10 μg/kg administered subcutaneously once daily for 5 days (up to 7 days if needed based on CD34⁺ yield).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of donors achieving a first apheresis yield of ≥ 4 × 10⁶ CD34⁺ cells/kg (donor weight).
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of donors achieving a yield of ≥ 2 × 10⁶ CD34⁺ cells/kg (donor weight) with no more than one apheresis.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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;
時間枠：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;
時間枠：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
時間枠：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)
|
協力者と研究者
協力者
捜査官
- 主任研究者：YI LUO、Zhejiang University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ZJU-GCSF
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
- CSR
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米国FDA規制医薬品の研究
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