NCT04539236

Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

A Multicenter, Phase Ib/II Study That Combines Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Mikkael Sekeres, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if the combination of drugs, Lenalidomide and Luspatercept, will help improve the treatment of anemia in patients with lower-risk Myelodysplastic Syndrome (MDS).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Lenalidomide	Administered daily by mouth on a 21 day cycle. Doses will be administered at 2.5 mg, 5 mg and 10 mg.
DRUG	Luspatercept	Administered subcutaneously in the upper arm, thigh and/or abdomen on Day 1 of a 21 day cycle. Starting dose will be at 1.0 mg/kg and can be titrated, dependent on participant response, to doses of 1.33 mg/kg, and 1.75 mg/kg.

Timeline

• Start date: 2021-11-09
• Primary completion: 2029-08-01
• Completion: 2029-08-01
• First posted: 2020-09-04
• Last updated: 2025-08-05

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study