Transplant-Related DisorderNCT06208137
Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.
A study testing Health monitoring and regular return follow-up reminders in people with Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Transplant-Related Disorder
- What is being tested?
- Health monitoring and regular return follow-up reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 1 Apr 2028
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) Patients must be ≥ 16 years of age;
- 2) Patients receiving haploidentical allo-HSCT;
- 3) Patients have to sign an informed consent form before the start of the research procedure.
Who cannot join
- 1) Tandem transplantation or multiple transplantations;
- 2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
- 3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Yahui Feng, MS, 022-23909051, fengyahui@ihcams.ac.cn
About this study
Official title: Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.
To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.
Read the detailed description
This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.
- Conditions
- Transplant-Related Disorder
- Being tested
- Health monitoring and regular return follow-up reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health monitoring and regular return follow-up remindersBehavioural
Health monitoring \& reminders for blood tests and follow-up visits until 1 year post-transplant
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Remind patients to test their immune status among 120-180 days post-transplantation. Physicians assessed the risk level of patients in the intervention group based on their immune status on days 91-180 using the CIRS. Receives: Behavioral: Health monitoring and regular return follow-up reminders |
| Control group | No intervention | Only remind patients to test their immune status among 120-180 days post-transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall survival during 1.5 years after transplantation
Measured: 1.5 years after transplantation
Secondary outcomes (3)
Non-relapse mortality rate
Non-relapse mortality rate during 1.5 years after transplantation
Measured: 1.5 years after transplantation
Incidence of infections
Infections during 1.5 years after transplantation
Measured: 1.5 years after transplantation
Immune cell count
Data on immune cell count will be collected during 1.5 years after transplantation
Measured: 1.5 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start29 Feb 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208137
- Sponsor's protocol ID
- IIT2023022
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06208137
- Acronym / sponsor ID
- IIT2023022
- Conditions
- Transplant-Related Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 17 Jan 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 assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.
Detailed description
This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health monitoring and regular return follow-up remindersRemind patients to test their immune status among 120-180 days post-transplantation. Physicians assessed the risk level of patients in the intervention group based on their immune status on days 91-180 using the CIRS. |
| Control group | No intervention | –Only remind patients to test their immune status among 120-180 days post-transplantation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Patients must be ≥ 16 years of age;
- 2) Patients receiving haploidentical allo-HSCT;
- 3) Patients have to sign an informed consent form before the start of the research procedure.
Key exclusion criteria (3 listed)
- 1) Tandem transplantation or multiple transplantations;
- 2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
- 3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health monitoring and regular return follow-up remindersHealth monitoring \& reminders for blood tests and follow-up visits until 1 year post-transplant | Behavioural | Intervention group |
Primary outcome
Survival
Time frame: 1.5 years after transplantation
Overall survival during 1.5 years after transplantation
3 secondary outcomes
Non-relapse mortality rate
Time frame: 1.5 years after transplantation
Incidence of infections
Time frame: 1.5 years after transplantation
Immune cell count
Time frame: 1.5 years after 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 13 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health monitoring and regular return follow-up reminders in people with Transplant-Related Disorder, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yahui Feng, MS (022-23909051, fengyahui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1.5 years after 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 13 Aug 2024.