A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
MDS
Interventions
DRUG

Lenalidomide and azacitidine combination

"lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."

Trial Locations (1)

60612

Rush University Medical Center, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Rush University Medical Center

OTHER

NCT01379274 - A Trial of Lenalidomide & Azacitidine in Low Risk Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter