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Reduced Intensity Conditioning for MDS

ConditionMDS
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-70
SponsorRuijin Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Fludarabine; melphalan; busulfan

    Drug

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: FBM armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

2-year relapse-free survival after transplantation

relapse

Time frame
through study completion, an average of 2 year

Secondary outcomes

1

2-year post-transplant survival

survival

Time frame
through study completion, an average of 2 year
2

Cumulative recurrence rate at 2 years post-transplant

relapse

Time frame
through study completion, an average of 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Wuhan TongJi Hospital

Collaborator

Wuhan Children's Hospital

Collaborator

Zhejiang University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: