Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT06704542

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-04-30

Brief Summary

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

Detailed Description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an important means of treating a variety of hematologic disorders. With the progress of HSCT technology, especially the research on haploidentical transplantation (HID-HSCT), the range of donor choices for hematological patients has been expanded, and theoretically, the era of "everyone has a donor" has been reached, which has increased the chances for hematological patients to receive allo-HSCT . The efficacy of allo-HSCT has improved dramatically over the past decades, but post-transplant complications such as graft-versus-host disease (GvHD), infections, and disease recurrence may still lead to treatment failure. In order to improve the efficacy of allo-HSCT, in addition to the improvement of pretreatment regimen and post-transplant management, the selection of the best donor among the many alternatives (including sibling donors, parents, children, and collateral hematologic donors, etc.) is still the focus and difficulty of clinical decision-making. The existing studies on donor selection have suggested that the factors to be considered include the number of HLA mismatched sites, donor-recipient consanguinity, donor age and gender, donor-specific antibody (DSA), NK cell isotype reactivity, and clonal hematopoiesis of the donor . However, little is known about whether a donor with metabolic syndrome such as diabetes affects post-transplant survival in allo-HSCT recipients.

It has been shown that diabetes mellitus affects the number and function of hematopoietic and immune cells, and that these effects may be passed on to progeny blood cells through epigenetic mechanisms, with long-term effects on immune cell function in diabetic patients. We therefore hypothesized that the effects of abnormal glucose metabolism in donors on the hematopoietic system may affect hematopoiesis and immune reconstitution in transplant recipients through "metabolic memory". Therefore, the investigator conduct a multicenter retrospective study through multifactorial survival regression. It is expected to provide new theoretical support for optimizing donor selection for allo-HSCT.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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%

No interventions assigned to this group

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)

No interventions assigned to this group

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hu Xiaoxia

Director of the Center for Translational Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jingtao Huang

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital of Huazhong University of Science and Technology, Wuhan

Wuhan, Hubei, China

Li Quan Hospital

Shanghai, Shanghai Municipality, China

Ruijin Hospital of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

The First Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hospital of Hematology of the Chinese Academy of Medical Sciences

Tianjin, , China

Countries

China

Central Contacts

Xiaoxia Hu

Role: CONTACT

hu_xiaoxia@126.com

(86) 13795437259

Facility Contacts

Weijie Cao

Role: primary

caoweijie2003@126.com

Yang Cao

Role: primary

yangcao@tjh.tjmu.edu.cn

Chun Wang

Role: primary

wangchun2@medmail.com.cn

Xiaoxia Hu, Doctor

Role: primary

hxx12276@rjh.com.cn

(86) 021-64370045

Yanmin Zhao

Role: primary

yanminzhao@zju.edu.cn

Yawei Zheng

Role: primary

zhengyawei@ihcams.ac.cn

Other Identifiers

RJBMT-07

Identifier Type: -

Identifier Source: org_study_id