Clinical Trials in China / NCT06704542
Starting soon
Observational
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation
NCT06704542 · tracked via the Priya Life Science China tracker
Condition(s) studied
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONDiabetes MellitusImpaired Fasting Glucose
Study summary
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Eligibility
Inclusion Criteria:
* Patients who underwent allogeneic hematopoietic stem cell transplantation (HSCT) between March 2019 and March 2024;
* Donor had fasting blood glucose and/or HbA1c records
* Eastern Cooperative Oncology Group (ECOG) physical fitness score of 0-2
* Survived at least 12 weeks after HSCT
* Voluntarily signed the Informed Consent Form
* Had appropriate organ function;
* Laboratory results within 7 days prior to HSCT met the following criteria:
1. Aspartate aminotransferase (AST) ≤ 3-fold (upper limit of norma, ULN);
2. Alanine aminotransferase (ALT) ≤ 3x ULN;
3. Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included;
4. Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
5. Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
Exclusion Criteria:
* Active autoimmune diseases such as SLE, rheumatoid arthritis, etc.
* Active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any Grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) Functional Class, or a history of myocardial infarction in the 6 months prior to screening;
* Other serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes);
* HIV infection, or chronic infection with hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV-positive) that cannot be controlled by medications;
* Patients with other uncured tumors
* Patients with neurological or psychiatric disorders
* Patients who were unable to understand or comply with the research protocol or are unable to sign the Informed Consent Form
Primary outcome measure(s)
- Overall Survival (OS) — One year-overall survival since hematopoietic stem cell transplantation
Patient's overall survival time since hematopoietic stem cell transplantation
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | |
| Tongji Hospital of Huazhong University of Science and Technology, Wuhan | Wuhan | Hubei | |
| Li Quan Hospital | Shanghai | Shanghai Municipality | |
| Ruijin Hospital of Shanghai Jiaotong University | Shanghai | Shanghai Municipality | |
| The First Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Hospital of Hematology of the Chinese Academy of Medical Sciences | Tianjin | China |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06704542 on ClinicalTrials.gov ↗ ← All trials in China