ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONNCT06704542
Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Diabetes Mellitus, run by Ruijin Hospital at 6 sites in China.
Trial summary
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Diabetes Mellitus, Impaired Fasting Glucose
- How many people
- 1,000 participants
- Where
- 6 sitesChina
- Study dates
- Nov 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were diagnosed with hematological disorders and underwent allo-HSCT
Who may be able to join
- 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;
Show all 12Show fewer
- 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;
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
The First Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Yanmin Zhao, yanminzhao@zju.edu.cn
Li Quan Hospital
Shanghai, Shanghai Municipality
Chun Wang, wangchun2@medmail.com.cn
Ruijin Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Xiaoxia Hu, Doctor, (86) 021-64370045, hxx12276@rjh.com.cn
Hospital of Hematology of the Chinese Academy of Medical Sciences
Tianjin
Yawei Zheng, zhengyawei@ihcams.ac.cn
Tongji Hospital of Huazhong University of Science and Technology, Wuhan
Wuhan, Hubei
Yang Cao, yangcao@tjh.tjmu.edu.cn
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Weijie Cao, caoweijie2003@126.com
About this study
Official title: A Study of the Impact of Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation Donors on Recipients' Post-Transplant Survival Outcomes: A Multicenter Retrospective Cohort Study Based on HIS Data
To investigate the impact of abnormal glucose tolerance in hematopoietic stem cell transplantation donors on patients' post-transplant survival outcomes.
Read the 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
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Patient's overall survival time since hematopoietic stem cell transplantation
Measured: One year-overall survival since hematopoietic stem cell transplantation
Secondary outcomes (7)
Non-relapse Mortality (NRM)
NRM after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
Relapse-free Survival (RFS)
RFS after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
Event-free Survival (EFS)
EFS after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
Graft versus Host Disease (GvHD) incidence
GvHD incidence after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
GvHD and Relapse-free Survival (GRFS)
GRFS incidence after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
Cumulative Incidence Rate (CIR)
CIR after hematopoietic stem cell transplantation
Measured: One year since hematopoietic stem cell transplantation
Graft Time of Different Cell Subpopulation
Graft Time of Platelet, Neutrophil
Measured: One year since hematopoietic stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATIONStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xiaoxia, Ruijin Hospital
- Investigators
- Jingtao Huang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704542
- Sponsor's protocol ID
- RJBMT-07
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Impact of Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation Donors on Recipients' Post-Transplant Survival Outcomes: A Multicenter Retrospective Cohort Study Based on HIS Data
- ClinicalTrials.gov ID
- NCT06704542
- Acronym / sponsor ID
- RJBMT-07
- Conditions
- ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Diabetes Mellitus, Impaired Fasting Glucose
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were diagnosed with hematological disorders and underwent allo-HSCT
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS)
Time frame: One year-overall survival since hematopoietic stem cell transplantation
Patient's overall survival time since hematopoietic stem cell transplantation
7 secondary outcomes
Non-relapse Mortality (NRM)
Time frame: One year since hematopoietic stem cell transplantation
Relapse-free Survival (RFS)
Time frame: One year since hematopoietic stem cell transplantation
Event-free Survival (EFS)
Time frame: One year since hematopoietic stem cell transplantation
Graft versus Host Disease (GvHD) incidence
Time frame: One year since hematopoietic stem cell transplantation
GvHD and Relapse-free Survival (GRFS)
Time frame: One year since hematopoietic stem cell transplantation
Cumulative Incidence Rate (CIR)
Time frame: One year since hematopoietic stem cell transplantation
Graft Time of Different Cell Subpopulation
Time frame: One year since hematopoietic stem cell transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingtao Huang principal investigator
Ruijin Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION and Diabetes Mellitus, run by Ruijin Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxia Hu ((86) 13795437259, hu_xiaoxia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: One year-overall survival since hematopoietic stem cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.