Myelodysplastic SyndromesPhase 2ImmBridgeNCT06918834
Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients
A Phase 2 study testing Immediate HSCT Group and Bridging Therapy Group in people with Myelodysplastic Syndromes, run by Institute of Hematology & Blood Diseases Hospital, China at 5 sites in China.
Trial summary
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Immediate HSCT Group and Bridging Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 5 sitesChina
- Study dates
- 24 Jul 2025to 1 Apr 2028
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- High relapse risk MDS, defined by:
- IPSS-R score ≥3.5.
- IPSS-M stratification as intermediate-high, high, or very high risk.
- Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
- Karnofsky Performance Status (KPS) ≥60.
- Signed informed consent.
Who cannot join
- Severe organ dysfunction:
- Left ventricular ejection fraction <50%.
- Oxygen supplementation requirement.
- Serum bilirubin >1.5x upper limit of normal (unless due to Gilbert syndrome) or AST/ALT >5x upper limit of normal.
- Estimated glomerular filtration rate (eGFR) <50 mL/min.
- History of prior allogeneic HSCT.
- Any condition deemed unsuitable by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Peking University People's Hospital
Beijin, Beijing Municipality, 100044
Hao Jiang
- Recruiting
People's Liberation Army The General Hospital of Western Theater Command
Chengdu, Sichuan, 610083
hai yi, +86-17760428229, yihaimail@163.com
yan deng, +86-15828495714, 285924840@qq.com
- Recruiting
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army
Jinan, Shandong
FANG ZHOU, +86-13969179221
- Recruiting
The Second Hospital of Hebei Medical University
Shijia Zhuang
Fuxu Wang, +86-13931100360, wfxhebmu@163.com
- Recruiting
Zhengzhou University First Affiliated Hospital
Zhengzhou, Henan, 450000
weijie cao, +86-15093360671, 945509679@qq.com
About this study
Official title: Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
Read the detailed description
A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Immediate HSCT Group, Bridging Therapy Group
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate HSCT GroupOther
Patients undergo direct allogeneic HSCT.
Bridging Therapy GroupOther
Patients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT.
- Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients.
| Study group | Role | What they receive |
|---|---|---|
| Immediate HSCT Group | Experimental | Not described Receives: Other: Immediate HSCT Group |
| Bridging Therapy Group | Active comparator | Not described Receives: Other: Bridging Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-Free Survival (DFS) post-HSCT
Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment
Measured: 2-year
Secondary outcomes (6)
Cumulative Incidence of Allogeneic HSCT
The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.
Measured: The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.
Complete Remission (CR) or CR Equivalent Rate from Randomization
The percentage of patients achieving CR or CR equivalent, defined as the first documented occurrence.
Measured: 2-year
2-year Overall Survival (OS) post-HSCT
Defined as the time from HSCT to death from any cause within two years.
Measured: 2-year
2-year Leukemia-Free Survival (LFS) from Randomization
The time from randomization to the occurrence of disease progression, relapse, or death from any cause within two years.
Measured: 2-year
2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization
Defined as the assessment of patient-reported QoL starting from randomization over a 2-year period, evaluated using the EORTC QLQ-C30 questionnaire.
Measured: 2-year
Molecular Clearance Rate
Molecular clearance was defined by two consecutive blood samples obtained at least 4 weeks apart after that were negative for driver mutations in a patient who had been positive before transplantation.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start24 Jul 2025
- Primary completion1 Apr 2028 (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 Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918834
- Sponsor's protocol ID
- IIT2025016
- Acronym
- ImmBridge
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2025
- Last updated
- 12 Sep 2025
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immediate Allogeneic Hematopoietic Stem Cell Transplantation Versus Bridging Therapy Followed by Transplantation in Higher-Risk Myelodysplastic Syndrome Patients: A Multicenter, Randomized Controlled, Open-Label, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06918834
- Acronym / sponsor ID
- ImmBridge / IIT2025016
- Conditions
- Myelodysplastic Syndromes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Apr 2025 (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.
This study aims to evaluate whether immediate allogeneic hematopoietic stem cell transplantation (HSCT) is non-inferior to HSCT following bridging therapy in patients with higher-risk myelodysplastic syndrome (HR-MDS).
Detailed description
A total of 236 patients will be randomized in a 1:1 ratio into the immediate transplantation group (n=118) and the disease control group (n=118). The study will continue until at least 124 events occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate HSCT Group | Experimental | Other: Immediate HSCT Group |
| Bridging Therapy Group | Active comparator | Other: Bridging Therapy Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- High relapse risk MDS, defined by:
- Eligible for allogeneic HSCT (including matched or mismatched related/unrelated donor transplantations).
- Karnofsky Performance Status (KPS) ≥60.
- Signed informed consent.
Key exclusion criteria (7 listed)
- Severe organ dysfunction:
- History of prior allogeneic HSCT.
- Any condition deemed unsuitable by the investigator.
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 |
|---|---|---|
| Immediate HSCT GroupPatients undergo direct allogeneic HSCT. | Other | Immediate HSCT Group |
| Bridging Therapy GroupPatients receive one to two cycles of bridging therapy before undergoing allogeneic HSCT. o Bridging Therapy Regimen: Hypomethylating agents (HMA) alone or HMA-based combination chemotherapy, e.g., azacitidine (AZA) 100 mg/day + venetoclax (VEN) 400 mg/day for 7 days. Targeted therapies (e.g., IDH1 inhibitors) will be used for eligible patients. | Other | Bridging Therapy Group |
Primary outcome
2-year Disease-Free Survival (DFS) post-HSCT
Time frame: 2-year
Defined as the time from transplantation to two years post-HSCT, with primary events including death or failure to achieve CR or CR equivalent at the time of assessment
6 secondary outcomes
Cumulative Incidence of Allogeneic HSCT
Time frame: The proportion of patients who undergo HSCT at 4, 8, 16, and 24 weeks post-randomization.
Complete Remission (CR) or CR Equivalent Rate from Randomization
Time frame: 2-year
2-year Overall Survival (OS) post-HSCT
Time frame: 2-year
2-year Leukemia-Free Survival (LFS) from Randomization
Time frame: 2-year
2-year Quality of Life (QoL) Assessment: 2-year Quality of Life (QoL) Assessment from Randomization
Time frame: 2-year
Molecular Clearance Rate
Time frame: 2-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 12 Sep 2025.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immediate HSCT Group and Bridging Therapy Group in people with Myelodysplastic Syndromes, run by Institute of Hematology & Blood Diseases Hospital, China at 5 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 7 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jiang Erlie, doctor (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease-Free Survival (DFS) post-HSCT (time frame: 2-year). 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 12 Sep 2025.