AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 3Ages 18 Years - 65 YearsAllFirst Affiliated Hospital of Zhejiang University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

National and international guidelines/consensus recommend G-CSF (granulocyte colony-stimulating factor) at 10 ฮผg/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 kidne

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-65 years. 2. Provision of written informed consent. 3. White blood cell (WBC) count \> 2.5 ร— 10โน/L. 4. Absolute neutrophil count (ANC) \> 1.5 ร— 10โน/L and platelet count \> 100 ร— 10โน/L. 5. Deemed suitable as a donor by the investigator based on donor physical examination and HLA matching. 6. Body weight โ‰ฅ 40 kg for females and โ‰ฅ 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.
๐Ÿ’Š

What it tests

  • Single-dose Granulocyte colony-stimulating factor (G-CSF)
  • Divided-dose Granulocyte colony-stimulating factor (G-CSF)
๐Ÿ“

Where

8 sites
Xiangya Hospital of Central South University
Changsha, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine.
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Jinhua Central Hospital
Jinhua, China
The Affiliated People's Hospital of Ningbo University
Ningbo, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy