Measurable Residual Disease Assessment of Cells With Leukemic Stem Cells Associated Phenotype in Patients With Myelodysplastic Syndrome: a Multi-center, Prospective Clinical Study

Not yet recruiting

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT06569095
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Unmanipulated haploidentical blood and bone marrow transplant candidates with<br> Myelodysplastic syndromes.<br><br> - Between 15 and 60 years-old.<br><br> - Patient in non-remission (NR) or positive for measurable residual disease prior to<br> transplantation.<br><br> - Subjects are able to provide written informed consent.<br><br>Exclusion Criteria:<br><br> - Subjects who cannot comply with the study.<br><br> - Patient has severe cardiac (ejection fraction <50%), hepatic (total bilirubin<br> >34umol/L, alanine aminotransferase, aspartate transaminase >2x upper limit of<br> normal) or renal (blood creatinine >130umol/L) disease.<br><br> - Uncontrolled serious infection.<br><br> - Other conditions that do not tolerate transplantation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year cumulative relapse rate

Secondary Outcome Measures

Name	Time	Method
Cumulative positive rate of measurable residual disease (MRD) after transplantation;Disease-free survival (LFS);Overall survival (OS);Non-recurrent death (NRM);Transplant-related death (TRM);Acute graft-versus-host disease (GVHD);Chronic graft-versus-host disease (GVHD)