Myelodysplastic Syndromes, AdultPhase 2NCT06612944
Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification
A Phase 2 study testing Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in people with Myelodysplastic Syndromes, Adult, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myelodysplastic Syndromes, Adult
- What is being tested?
- Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2024to 12 Nov 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years, inclusive, both male and female. Diagnosed with MDS according to WHO criteria and classified as very high-risk by IPSS-M scoring. The patient must have a suitable hematopoietic stem cell donor for allogeneic transplantation: Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1
- Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of ≤ 2. ECOG performance status of 0-2. Adequate liver, kidney, cardiac, and pulmonary functions as follows: Serum creatinine ≤ 1.5× upper limit of normal (ULN)
- Cardiac function: Ejection fraction ≥ 50%
- Baseline oxygen saturation \> 92%
- Total bilirubin ≤ 1.5× ULN
- ALT and AST ≤ 2.0× ULN
- Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 ≥ 50%. Patients must be capable of understanding and willing to participate in the study, and must sign an informed consent form.
Who cannot join
- Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning. History of previous hematopoietic stem cell transplantation (HSCT). ECOG performance status \> 2. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3. Any unstable systemic disease including, but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within the past 3 months, myocardial infarction within the past 3 months, congestive heart failure (New York Heart Association [NYHA] class ≥ III), post-pacemaker implantation requiring medication for severe arrhythmias, severe liver, kidney, or metabolic diseases
- patients with pulmonary arterial hypertension. Active, uncontrolled infection: hemodynamic instability related to infection, new symptoms or signs of worsening infection, radiological evidence of new infectious foci, persistent fever without signs or symptoms that cannot exclude infection. Need for treatment for Grade ≥2 epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson\'s disease, schizophrenia. HIV infection. Active hepatitis B (HBV) or hepatitis C (HCV) requiring antiviral treatment
- patients at risk of HBV reactivation, indicated by positive hepatitis B surface antigen or core antibody without antiviral therapy for hepatitis B. Pregnant or breastfeeding women. Men and women of childbearing potential unwilling to use contraception during the treatment and for 12 months post-treatment. Allergic to intervention drugs such as azacitidine, decitabine, or venetoclax.
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
Shanghai General Hospital
Shanghai, 200080
Wu Huixian, +86 18621127020, 1011825696@qq.com
About this study
Official title: Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification: A Single-Arm, Prospective, Single-Center Clinical Study
By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells \> 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.
- Conditions
- Myelodysplastic Syndromes, Adult
- Being tested
- Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Intervention for Relapse Prevention Post-Allogeneic TransplantationDrug
1.1 AZA + BCL2 Inhibitor (Preferred Regimen) Subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; BCL2 inhibitor (VEN): 400 mg per day orally for one week (if combined with a CYP450 inhibitor, reduce to 100 mg per day).
1.2 AZA (DEC) + DLI For patients with TP53 mutations or those who do not respond to VEN, subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; decitabine at 5 mg/m² per day for 5 consecutive days, with a 28-day cycle (preferred for those with TP53 mutations). For patients without the option for DLI, regimen 1.1 is recommended.
DLI: Begins 3 months post-transplantation, starting with a dose of 1×10^5 CD3+ T lymphocytes for haploidentical transplants, with doses increasing every 4-6 weeks to 5×10^5 CD3+ T lymphocytes, 1×10^6 CD3+, and 5×10^6 CD3+ T lymphocytes; for full-matched transplants, the starting dose is 5×10^5 CD3+ T lymphocytes with dose escalations as above to 1×1
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Drug: Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS：relapse-free survival
Measured: 1 year
RFS：relapse- free survival
Measured: 2 year
Secondary outcomes (2)
OS：overall survival
Measured: 1 year
OS：overall survival
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 posted25 Sep 2024
- Study start12 Nov 2024
- Primary completion12 Nov 2027 (estimated)
- Study completion12 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic Syndromes, AdultStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612944
- Sponsor's protocol ID
- SHSYXY-202405-IPSSM-MDS
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in Very High-Risk MDS Patients Based on IPSS-M Stratification: A Single-Arm, Prospective, Single-Center Clinical Study
- ClinicalTrials.gov ID
- NCT06612944
- Acronym / sponsor ID
- SHSYXY-202405-IPSSM-MDS
- Conditions
- Myelodysplastic Syndromes, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 12 Nov 2027 (estimated)
- Study completion
- 12 Nov 2028 (estimated)
- First posted
- 25 Sep 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.
By collecting interventional clinical data to assess the survival and relapse conditions of patients post-transplantation and comparing them with historical data, the primary study endpoint is the 1-year and 2-year relapse-free survival (RFS) post-transplantation. This includes the time from the start of treatment until the documentation of disease progression (bone marrow smear blast cells \> 5% or extramedullary relapse) or death due to any cause, whichever occurs first. This experiment aims to improve the post-transplant survival rates of MDS patients classified as very high risk under the IPSS-M stratification and to explore pathways to prevent relapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 70 years, inclusive, both male and female. Diagnosed with MDS according to WHO criteria and classified as very high-risk by IPSS-M scoring. The patient must have a suitable hematopoietic stem cell donor for allogeneic transplantation: Related donors must be at least 5/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1
- Unrelated donors must be at least 8/10 matched for HLA-A, -B, -C, -DQB1, and -DRB1. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of ≤ 2. ECOG performance status of 0-2. Adequate liver, kidney, cardiac, and pulmonary functions as follows: Serum creatinine ≤ 1.5× upper limit of normal (ULN)
- Cardiac function: Ejection fraction ≥ 50%
- Baseline oxygen saturation \> 92%
- Total bilirubin ≤ 1.5× ULN
Key exclusion criteria (3 listed)
- Failure to proceed with stem cell reinfusion after unsuccessful pre-transplant conditioning. History of previous hematopoietic stem cell transplantation (HSCT). ECOG performance status \> 2. Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score ≥ 3. Any unstable systemic disease including, but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack within the past 3 months, myocardial infarction within the past 3 months, congestive heart failure (New York Heart Association [NYHA] class ≥ III), post-pacemaker implantation requiring medication for severe arrhythmias, severe liver, kidney, or metabolic diseases
- patients with pulmonary arterial hypertension. Active, uncontrolled infection: hemodynamic instability related to infection, new symptoms or signs of worsening infection, radiological evidence of new infectious foci, persistent fever without signs or symptoms that cannot exclude infection. Need for treatment for Grade ≥2 epilepsy, paralysis, aphasia, new cerebral infarction, severe brain trauma, dementia, Parkinson\'s disease, schizophrenia. HIV infection. Active hepatitis B (HBV) or hepatitis C (HCV) requiring antiviral treatment
- patients at risk of HBV reactivation, indicated by positive hepatitis B surface antigen or core antibody without antiviral therapy for hepatitis B. Pregnant or breastfeeding women. Men and women of childbearing potential unwilling to use contraception during the treatment and for 12 months post-treatment. Allergic to intervention drugs such as azacitidine, decitabine, or venetoclax.
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 |
|---|---|---|
| Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation1.1 AZA + BCL2 Inhibitor (Preferred Regimen) Subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; BCL2 inhibitor (VEN): 400 mg per day orally for one week (if combined with a CYP450 inhibitor, reduce to 100 mg per day). 1.2 AZA (DEC) + DLI For patients with TP53 mutations or those who do not respond to VEN, subcutaneous injection of azacitidine at 32 mg/m² per day for 5 consecutive days, with a 28-day cycle; decitabine at 5 mg/m² per day for 5 consecutive days, with a 28-day cycle (preferred for those with TP53 mutations). For patients without the option for DLI, regimen 1.1 is recommended. DLI: Begins 3 months post-transplantation, starting with a dose of 1×10^5 CD3+ T lymphocytes for haploidentical transplants, with doses increasing every 4-6 weeks to 5×10^5 CD3+ T lymphocytes, 1×10^6 CD3+, and 5×10^6 CD3+ T lymphocytes; for full-matched transplants, the starting dose is 5×10^5 CD3+ T lymphocytes with dose escalations as above to 1×1 | Drug | Intervention Group |
Primary outcome
RFS：relapse-free survival
Time frame: 1 year
RFS：relapse- free survival
Time frame: 2 year
2 secondary outcomes
OS：overall survival
Time frame: 1 year
OS：overall survival
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 26 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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 Phase 2 study testing Prophylactic Intervention for Relapse Prevention Post-Allogeneic Transplantation in people with Myelodysplastic Syndromes, Adult, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 7 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 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 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.
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 Xianmin Song, MD (+8613501672508, shongxm@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS：relapse-free survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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.