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NCT07085156

PHASE2

Reduced Intensity Conditioning for MDS

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of Reduced-Intensity Conditioning With Fludarabine- Melphalan-Busulfan for Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Myelodysplastic Syndromes

Key Details

Gender

All

Age Range

14 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-01

Completion Date

2028-05-01

Last Updated

2025-07-25

Healthy Volunteers

Conditions

MDS

Interventions

DRUG

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.

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;

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China