Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation

NCT06704542 | Not Yet Recruiting

• 1 other identifier: RJBMT-07
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; Diabetes Mellitus; Impaired Fasting Glucose

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Patient's overall survival time since hematopoietic stem cell transplantation

  One year-overall survival since hematopoietic stem cell transplantation

Secondary Outcomes (7)

• Non-relapse Mortality (NRM)

  One year since hematopoietic stem cell transplantation

• Relapse-free Survival (RFS)

  One year since hematopoietic stem cell transplantation

• Event-free Survival (EFS)

  One year since hematopoietic stem cell transplantation

• Graft versus Host Disease (GvHD) incidence

  One year since hematopoietic stem cell transplantation

• GvHD and Relapse-free Survival (GRFS)

  One year since hematopoietic stem cell transplantation

Study Arms (2)

Case Group

patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose ≥6.1 mmol/L or HbA1c ≥5.7%

Control Group

patients who underwent allogeneic hematopoietic stem cell transplantation from March 2019 to March 2024; donor fasting blood glucose and/or HbA1c data available; fasting blood glucose \<6.1 mmol/L; HbA1c \<5.7% (if available)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with hematological disorders and underwent allo-HSCT

You may qualify if:

• 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:
• Aspartate aminotransferase (AST) ≤ 3-fold (upper limit of norma, ULN);
• Alanine aminotransferase (ALT) ≤ 3x ULN;
• 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;
• Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min;
• Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (6)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Tongji Hospital of Huazhong University of Science and Technology, Wuhan

Wuhan, Hubei, China

Location

Li Quan Hospital

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

The First Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Hospital of Hematology of the Chinese Academy of Medical Sciences

Tianjin, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

1\. Peripheral blood/bone marrow specimens from post-transplant patients. 2. Peripheral blood stem cell grafts from donors.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jingtao Huang

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoxia Hu

CONTACT

(86) 13795437259; hu_xiaoxia@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Center for Translational Medicine

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)