A Phase 3b, open-label, single-arm, rollover study to evaluate long-term safety in subjects who have participated in other luspatercept (ACE-536, also known as BMS 986346) clinical trials.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502498-40-00

Acronym

ACE-536-LTFU-001

Enrollment

139

Registered

2024-02-20

Start date

2019-07-26

Completion date

Unknown

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndrome (MDS); beta (β)-thalassemia (THAL); myelofibrosis (MF)

Brief summary

Adverse events (AEs), Progression to high/very high-risk myelodysplastic syndrome (MDS), Progression to Acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only), Development of other malignancies/premalignancies

Detailed description

Overall survival, Treatment-emergent EMH masses

Interventions

DRUGReblozyl 75 mg powder for solution for injection

DRUGReblozyl 25 mg powder for solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs), Progression to high/very high-risk myelodysplastic syndrome (MDS), Progression to Acute myeloid leukemia (AML) (MDS and myelofibrosis [MF] only), Development of other malignancies/premalignancies	—

Secondary

Measure	Time frame
Overall survival, Treatment-emergent EMH masses	—

Countries

Bulgaria, France, Germany, Greece, Italy, Netherlands, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026