Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation

Launched by RUIJIN HOSPITAL · Nov 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how abnormal blood sugar levels in donors of stem cells might affect the survival of patients who receive those stem cells during a transplant. It aims to better understand the connection between the donor's glucose tolerance and the patient's outcomes after the transplant. The trial is not yet recruiting participants, but it will include patients who had an allogeneic hematopoietic stem cell transplant between March 2019 and March 2024. To be eligible, patients must have specific health criteria, such as good organ function and a certain level of fitness, and they must have survived at least 12 weeks after the transplant.

Participants in this study will be asked to agree to take part voluntarily, and they will need to have certain medical tests done to ensure they are suitable for the trial. It's important to note that people with active autoimmune diseases, serious heart conditions, or other significant health issues may not be able to participate. By understanding how donor glucose levels affect patient recovery, the researchers hope to improve care for future transplant patients.

Gender

ALL

Eligibility criteria

• 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