drugset / Trial / NCT00840931
Immunotherapy Using Lenalidomide + Bystander Vaccine in High Risk Myelodysplastic Syndrome (MDS)
Phase 1
Completed
22 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).
Timeline
- Start
- 2009-02-02
- Primary completion
- 2014-02-17
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM.CD40L | Vaccine | 1e+07 cells | — |
| Subject | GM.CD40L | Vaccine | 3e+07 cells | — |
| Subject | GM.CD40L | Vaccine | 6e+07 cells | — |
| Subject | GM.CD40L | Vaccine | 1.2e+08 cells | — |
| Subject | Lenalidomide | Other / unclassified | 10 mg | — |