NCT07085156Not yet recruitingPhase 2
Reduced Intensity Conditioning for MDS
The Efficacy and Safety of Reduced-Intensity Conditioning With Fludarabine- Melphalan-Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myelodysplastic Syndromes
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 6 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 May 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT07085156
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 1 Aug 2025 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.