Multi-center non-randomized open trial to evaluate the efficacy of azacitidine followed by allo-HSCT for TP53(+) MDS.

Not Applicable

• Conditions: myelodysplastic syndromes

• Registration Number: JPRN-UMIN000027789
• Lead Sponsor: Japan Agency for Medical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-20
• Last Update Posted: 17 October 2023
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Previous history of allo-HSCT. (2) Obviously refractory to azacitidine, or planning allo-HSCT for disease progression after azacitidine treatment. (3) Active comorbid malignancy (less than 5 years after cure) except for myeloid malignancies that are assumed to be associated with MDS development. (4) Have uncontrollable infections. (5) Have psychiatric disorders requiring major tranquilizers. (6) During pregnancy or suspected pregnancy. (7) Positive for either HBs-Ag, HCV-Ab, HIV-Ab. (8) Assumed inappropriate to register the study by the attending doctors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year OS after allogeneic hematopoietic stem cell transplantation.