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

PHASE1/PHASE2SuspendedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

November 9, 2021

Primary Completion Date

August 1, 2029

Study Completion Date

August 1, 2029

Conditions
Myelodysplastic Syndromes
Interventions
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.

Trial Locations (5)

21287

Johns Hopkins University, Baltimore

33136

University of Miami, Miami

44195

Cleveland Clinic, Cleveland

75390

University of Texas Southwestern Medical Center, Dallas

02215

Dana-Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
collaborator

Celgene

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Mikkael Sekeres, MD

OTHER