Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 2, 2009

Primary Completion Date

February 17, 2014

Study Completion Date

December 31, 2019

Conditions
Leukemia
Interventions
DRUG

lenalidomide

Patients will take 10 mg capsules of lenalidomide per day for 21 days followed by 7 days of rest. This 28 day period is considered 1 cycle. Patients will receive 4 treatment cycles with 28 days in each cycle.

BIOLOGICAL

bystander vaccine

In addition to lenalidomide, during each 28 day cycle patients will also receive GM.CD40L bystander vaccination injections in 2-week intervals on days 8 and 22 for a total of 8 immunizations during the 4 cycle treatment period.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00840931 - Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter