Myelodysplastic SyndromesNCT06279338
A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score
A study testing Azacitidine Injection in people with Myelodysplastic Syndromes, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score 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?
- Azacitidine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients fully understand this study, voluntarily participate and sign the informed consent form
- Age equal or more than 18 years old
- Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
- Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%
Who cannot join
- Patients who refuse to participate in this clinical study
- Patients with central nervous system involvement
- Patients with HIV seropositive
- Patients with other serious medical conditions with a life expectancy of less than six months
- Patients with severe psychiatric or psychological disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study of Azacitidine Combined With BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score
Read the detailed description
This study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine (AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and safety of azacitidine plus BUCY2 pretreatment regimen.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Azacitidine Injection
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Molecular International Prognostic Scoring System (IPSS-M), Azacitidine
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine InjectionDrug
Also called Azacitidine
On the basis of the conventional transplantation treatment regimen, combining azacitidine injection with BUCY2 conditioning regimen (azacitidine 75 mg/m2/d for -11 days to -5 days, cytarabine 2 g/m2 q12h for -8 days to -7 days, cyclophosphamide 1.8 g/m2/d for -6 days to -5 days, busulfan 3.2 mg/kg/d for -4 days to -2 days)
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine | Experimental | Combining azacitidine with classic BUCY2 regimen as conditioning regimen Receives: Drug: Azacitidine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) at 18 months post-transplant, month
PFS is measured from the date of allo-HSCT to the date of relapse or death from any cause or the last follow-up for surviving patients.
Measured: 18 months post-transplantation
Secondary outcomes (1)
Overall survival (OS) at 18 months post-transplant, month
OS is defined as the time from allo-HSCT to the date of death from any cause or the last follow-up for surviving patients.
Measured: 18 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Treatment
- 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
- Sponsor
- Investigators
- Linghui Xia, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279338
- Sponsor's protocol ID
- [2023] No.0969
- Status last verified
- Jan 2024
- First submitted
- 1 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Azacitidine Combined With BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome With Moderate High IPSS-M Score
- ClinicalTrials.gov ID
- NCT06279338
- Acronym / sponsor ID
- [2023] No.0969
- Conditions
- Myelodysplastic Syndromes
- Keywords
- Allogeneic Hematopoietic Stem Cell Transplantation, Molecular International Prognostic Scoring System (IPSS-M), Azacitidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 Feb 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.
Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score
Detailed description
This study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine (AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and safety of azacitidine plus BUCY2 pretreatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine | Experimental | Drug: Azacitidine InjectionCombining azacitidine with classic BUCY2 regimen as conditioning regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients fully understand this study, voluntarily participate and sign the informed consent form
- Age equal or more than 18 years old
- Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
- Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%
Key exclusion criteria (5 listed)
- Patients who refuse to participate in this clinical study
- Patients with central nervous system involvement
- Patients with HIV seropositive
- Patients with other serious medical conditions with a life expectancy of less than six months
- Patients with severe psychiatric or psychological disorders
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 |
|---|---|---|
| Azacitidine InjectionAlso: AzacitidineOn the basis of the conventional transplantation treatment regimen, combining azacitidine injection with BUCY2 conditioning regimen (azacitidine 75 mg/m2/d for -11 days to -5 days, cytarabine 2 g/m2 q12h for -8 days to -7 days, cyclophosphamide 1.8 g/m2/d for -6 days to -5 days, busulfan 3.2 mg/kg/d for -4 days to -2 days) | Drug | Azacitidine |
Primary outcome
Progression-free survival (PFS) at 18 months post-transplant, month
Time frame: 18 months post-transplantation
PFS is measured from the date of allo-HSCT to the date of relapse or death from any cause or the last follow-up for surviving patients.
1 secondary outcome
Overall survival (OS) at 18 months post-transplant, month
Time frame: 18 months post-transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Low Risk Myelodysplastic Syndromes
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
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. This study is not recruiting at the moment.
Linghui Xia principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Azacitidine Injection in people with Myelodysplastic Syndromes, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiena Cao (0086-13031186262, caoxiena@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) at 18 months post-transplant, month (time frame: 18 months post-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 28 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.