Milder Preparation Before Stem Cell Transplant for Myelodysplastic Syndromes
Tests a gentler conditioning regimen before stem cell transplant in people with myelodysplastic syndromes.
Plain-language title generated from the registry record
Registry title: Reduced Intensity Conditioning for MDS
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 14 to 70 with myelodysplastic syndrome (MDS) who are having a donor stem cell transplant. It tests a gentler conditioning treatment with fludarabine, melphalan and busulfan.
- Age
- 14 to 70 years, including both limits.
- Sex
- All sexes can join.
- Disease stage
- MDS confirmed by bone marrow and genetic tests. Intermediate-risk or higher-risk by IPSS-R or IPSS-M, or MDS that needs blood transfusions.
Main reasons for not taking part
- Allergy or contraindication to any drug in the protocol
- Serious active heart disease, or a heart attack within the 6 months before screening
- Serious illness such as ongoing infection or uncontrolled diabetes
- Active autoimmune disease such as SLE or rheumatoid arthritis
- Pregnant or breastfeeding
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 70 years old?
Source: NCT07085156, who can take part
Where in China
- Ruijin Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaContact: Xiaoxia HU, DoctorNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07085156
- Record updated
- 25 July 2025
- Original description
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only potential cure for Myelodysplastic syndrome (MDS). Currently, the conditioning regimen for MDS allogeneic transplantation still follows AML, and there are fewer explorations in this field. In a large-scale retrospective analysis with 532 MDS undergoing allo-HCT, reduced intensity conditioning is resulted in improved overall survival (OS), reduced non-relapse mortality (NRM) , while sparing relapse.Read full original descriptionShow less
The Efficacy and Safety of Reduced-Intensity Conditioning With Fludarabine- Melphalan-Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myelodysplastic Syndromes
Allogeneic hematopoietic cell transplantation (allo-HCT) is the only potential cure for Myelodysplastic syndrome (MDS). Currently, the conditioning regimen for MDS allogeneic transplantation still follows AML, and there are fewer explorations in this field. In a large-scale retrospective analysis with 532 MDS undergoing allo-HCT, reduced intensity conditioning is resulted in improved overall survival (OS), reduced non-relapse mortality (NRM) , while sparing relapse.
Therefore, the investigators conduct a prospective, single-arm, multicentre study to evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan reduced-intensity conditioning in MDS patients.
Inclusion: Age 14-70 (including boundaries) and gender; Diagnosis of MDS is confirmed on the basis of bone marrow cytomorphology, immunophenotyping and chromosomal and molecular biology tests; IPSS-R intermediate-risk or higher-risk or IPSS-M intermediate-risk or higher-risk MDS; transfusion-dependent MDS; ECOG score≤ 3 points; Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:; Aspartate aminotransferase (AST) ≤ 3 times ULN (upper limit of normal, ULN); Alanine aminotransferase (ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5 times the upper limit of normal ULN unless the patient has documented Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min; Coagulation function: International Normalised Ratio (INR) ≤ 1.5 x ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN; Left ventricular ejection fraction (LVEF) ≥50%; Voluntarily signing the informed consent, understanding and complying with the requirements of the study, good compliance, and cooperating with the follow-up visits.
Exclusion: Currently have clinically significant active cardiovascular disease such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening; Allergies or contraindications to any of the drugs in the protocol; Serious medical conditions that may limit the patient's participation in this trial (e.g., progressive infection, uncontrolled diabetes); Active autoimmune diseases such as SLE, rheumatoid arthritis, etc; Patients with neurological or psychiatric disorders; Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study; The patient is pregnant or breastfeeding; Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form.