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Not yet recruiting NCT07085156

Reduced Intensity Conditioning for MDS

Phase II Interventional MDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fludarabine; melphalan; busulfan.
Who it may be relevant to
Registry conditions: MDS. Basic parameters: 14 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Detailed description

This study is a prospective, multicenterstudy designed to evaluate the efficacy and safety of evaluate the efficacy and safety of Fludarabine-Melphalan-Busulfan intermediate-intensity transplantation conditioning regimen for the treatment of MDS. . Patients with MDS who are eligible for enrolment were pretreated with a Fludarabine-Melphalan-Busulfan regimen (Fludarabine 30mg/m2d-6 to -2; melphalan 70mg/m2d-6; busulfan 3.2mg/kg d-4 to -3). The primary endpoint is 2-year relapse-free survival (RFS) after transplantation. Secondary endpoints includes 2-year post-transplant survival (OS) and cumulative recurrence rate at 2 years post-transplant.

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.

Primary outcome measures

  • 2-year relapse-free survival after transplantation [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (2)
  • 2-year post-transplant survival [Time frame: through study completion, an average of 2 year]
  • Cumulative recurrence rate at 2 years post-transplant [Time frame: through study completion, an average of 2 year]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07085156 · RJ-BMT-012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗