Fludarabine; melphalan; busulfan: The conditioning regimen includes fludarabine, busulfan, and melphalan, with a transplant conditioning intensity of 3.0. The RIC is used in the allo-HCT in the MDS patients.
Study summary
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.
Eligibility
Sex
ALL
Min age
14 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* Allergies or contraindications to any of the drugs in the protocol;
* 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;
* 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;
* 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.
* Other conditions that, in the opinion of the investigator, make the patient otherwise unsuitable for participation in this study;
Primary outcome measure(s)
2-year relapse-free survival after transplantation — through study completion, an average of 2 year relapse
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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