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NOT YET RECRUITING
NCT06927232
PHASE3

AZA+Lus VS AZA Monotherapy in HR-MDS

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.

Official title: Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2025-04

Completion Date

2027-01-31

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

DRUG

Azacitidine (AZA)

Azacitidine 75mg/m/ day \*5 days, 28 days for 1 course

DRUG

Luspatercept

Luspatercept 1.0 mg/kg subcutaneously every 3 weeks, adjusted according to hemoglobin, up to 1.75mg/kg. If hemoglobin ≥120g/L, luspatercept can be discontinued.