Allogeneic Hematopoietic Stem Cell TransplantationNCT06708130
Allogeneic Hematopoietic Stem Cell Transplantation Cohort Study
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation, run by Ruijin Hospital at 3 sites in China.
Trial summary
Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- How many people
- 3,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 May 2021to 31 Dec 2031
- 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 are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation
Who may be able to join
- At least one visit to a stem cell transplant center beginning January 1, 2021
- Proposed to undergo or have undergone hematopoietic stem cell transplantation
Who cannot join
- Long-term follow-up information for patients not available for any reason (e.g., unavailable or with serious concomitant disease) according to investigator opinion
- Due to alcohol and drug addiction thus affecting their ability to follow the requirements of the study
- Presence of conditions that could jeopardize patient safety or affect their adherence to the protocol, according to the investigator's opinion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Xiaoxia Hu, (86) 13795437259, hu_xiaoxia@126.com
- Not yet recruiting
Shanghai Liquan Hospital
Shanghai
Chun Wang, (86) 13386259777
- Not yet recruiting
Shanghai Zhaxin Hospital
Shanghai
Chun Wang, (86) 13386259777
About this study
Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing the burden of disease
Read the detailed description
This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.
The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).
During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.
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 |
|---|---|---|
| Cohort 1 | Patients who are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation at the Stem Cell Transplant Center and Post-Transplant Medical Consortium at Regent Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS since enrollment
Measured: Time Frame: through study completion, an average of 5 year
Secondary outcomes (7)
Strictly complete remission (sCR)
Strictly complete remission (sCR)
Measured: Time Frame: through study completion, an average of 5 year
Complete remission (CR)
Complete remission (CR)
Measured: Time Frame: through study completion, an average of 5 year
Very Good Partial Relief (VGPR)
Very Good Partial Relief (VGPR)
Measured: Time Frame: through study completion, an average of 5 year
Partial remission (PR)
Partial remission (PR)
Measured: Time Frame: through study completion, an average of 5 year
Minor Relief (MR)
Minor Relief (MR)
Measured: Time Frame: through study completion, an average of 5 year
Disease stabilization (SD)
Disease stabilization (SD)
Measured: Time Frame: through study completion, an average of 5 year
Progression of Disease (PD)
Progression of Disease (PD)
Measured: Time Frame: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 May 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Xiaoxia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708130
- Sponsor's protocol ID
- RJ-BMT
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Huang J, Jiang C, Huang M, Guo X, Li S, Zhang Z, Huang J, Lu H, Pan Z, Zhu J, Chen Q, He Y, Cao Y, Hu X. Letermovir Prophylaxis Guided by Cytomegalovirus Cell-Mediated Immunity Improves the Outcomes of Allogeneic Hematopoietic Stem Cell Transplant Recipients. Clin Infect Dis. 2026 Apr 30;82(4):597-606. doi: 10.1093/cid/ciaf410.
PubMed 40705849
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation Cohort Study
- ClinicalTrials.gov ID
- NCT06708130
- Acronym / sponsor ID
- RJ-BMT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 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.
Clinical observational studies using epidemiologic theories and methods. Through the collection of various clinically relevant data, specific outcomes are evaluated in hematologic transplant patients, providing high quality real-world data for clinical practice, informing public health decision-making, and reducing the burden of disease
Detailed description
This is a retrospective, prospective, two-way cohort study in which clinical diagnostic and treatment data will be collected on patients enrolled in the study and followed up to characterize the natural course of the patient population as systematically as possible. All treatment decisions and clinical assessments will be made by the treating physician based on conventional treatment criteria and are not required by the study design or protocol.
The purpose of this study is to examine the natural course of the disease and current treatments. An in-depth analysis of treatment regimens and treatment duration, as well as the sequence of regimen use, will be conducted to describe treatment modalities and healthcare expenditures for this disease state. No clinical device or laboratory/assessment interventions will be conducted except for disease management requirements based on routine practice requirements or treatment monitoring based on locally approved product characterization requirements. Patients will be required to complete a separate questionnaire containing basic epidemiologic information (demographics, disease history, environmental exposure history).
During the duration of this study, some patients may be enrolled in interventional clinical trials. This is allowed and expected to occur in this study. Patients will not be required to withdraw from the cohort study and will continue to be followed up as normal, unless the investigator/patient feels it is more appropriate to withdraw from the study. All requirements of the clinical trial in question are documented according to the trial protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients who are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation at the Stem Cell Transplant Center and Post-Transplant Medical Consortium at Regent Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are proposed to undergo or have undergone allogeneic hematopoietic stem cell transplantation
Key inclusion criteria (2 listed)
- At least one visit to a stem cell transplant center beginning January 1, 2021
- Proposed to undergo or have undergone hematopoietic stem cell transplantation
Key exclusion criteria (3 listed)
- Long-term follow-up information for patients not available for any reason (e.g., unavailable or with serious concomitant disease) according to investigator opinion
- Due to alcohol and drug addiction thus affecting their ability to follow the requirements of the study
- Presence of conditions that could jeopardize patient safety or affect their adherence to the protocol, according to the investigator's opinion
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: Time Frame: through study completion, an average of 5 year
OS since enrollment
7 secondary outcomes
Strictly complete remission (sCR)
Time frame: Time Frame: through study completion, an average of 5 year
Complete remission (CR)
Time frame: Time Frame: through study completion, an average of 5 year
Very Good Partial Relief (VGPR)
Time frame: Time Frame: through study completion, an average of 5 year
Partial remission (PR)
Time frame: Time Frame: through study completion, an average of 5 year
Minor Relief (MR)
Time frame: Time Frame: through study completion, an average of 5 year
Disease stabilization (SD)
Time frame: Time Frame: through study completion, an average of 5 year
Progression of Disease (PD)
Time frame: Time Frame: through study completion, an average of 5 year
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 27 Nov 2024.
- Derived from this study: PubMed 40705849Wang L, Huang J, Jiang C, Huang M, Guo X, Li S, Zhang Z, Huang J, Lu H, Pan Z, Zhu J, Chen Q, He Y, Cao Y, Hu X. Letermovir Prophylaxis Guided by Cytomegalovirus Cell-Mediated Immunity Improves the Outcomes of Allogeneic Hematopoietic Stem Cell Transplant Recipients. Clin Infect Dis. 2026 Apr 30;82(4):597-606. doi: 10.1093/cid/ciaf410.
- 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.
3 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, run by Ruijin Hospital at 3 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 2 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 27 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 3 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: Time Frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708130, which also lists 1 linked publication.
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 27 Nov 2024.