A phase II, open-label, single arm study to evaluate the efficacy of Luspatercept in Erythropoiesis-stimulating agent naive lower-risk MDS patients with or without ring sideroblasts who do not require RBC transfusions (LENNON)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516438-36-00

Acronym

LENNON

Enrollment

Registered

2024-08-16

Start date

2022-09-13

Completion date

Unknown

Last updated

2025-07-17

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

Conditions

Patients with very low, low or intermediate risk myelodysplastic syndromes (MDS) presenting with anemia, transfusion independence (NTD) and naive towards ESA treatment

Brief summary

The primary efficacy endpoint is erythroid response (HI-E) according to IWG 2018 criteria and defined as an increase in hemoglobin levels by at least 1.5 g/dL, persistent for at least 8 weeks over the baseline hemoglobin level (mean over 16 weeks prior to inclusion) and will be determined after 24 weeks of LUS treatment.

Detailed description

To evaluate HI-E response duration on a time horizon of 18 months after response

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
The primary efficacy endpoint is erythroid response (HI-E) according to IWG 2018 criteria and defined as an increase in hemoglobin levels by at least 1.5 g/dL, persistent for at least 8 weeks over the baseline hemoglobin level (mean over 16 weeks prior to inclusion) and will be determined after 24 weeks of LUS treatment.	—

Secondary

Measure	Time frame
To evaluate HI-E response duration on a time horizon of 18 months after response	—

Countries

Germany

Outcome results

None listed

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