Ignite Creation Date:
2024-05-05 @ 9:15 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00840931
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2009-02-04
Brief Title:
Immunotherapy Using Lenalidomide Bystander Vaccine in High Risk Myelodysplastic Syndrome MDS
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Pilot Study of Immunotherapy Using Lenalidomide Plus Bystander Vaccine in Patients With High-Risk Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out the maximum tolerated dose MTD of the combined therapy of lenalidomide Revlimid and Granulocytemacrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line GMCD40L bystander vaccine This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome MDS
Detailed Description:
Fixed dose of lenalidomide at 10 mgday Days 1- 21 of 28 days of treatment cycle and 4 dose escalations of GMCD40L vaccine 10 X 106 GMCDL cells per vaccination 30 X 106 GMCDL cells per vaccination 60 X 106 GMCDL cells per vaccination 120 X 106 GMCDL cells per vaccination Vaccination at 2-week intervals on days 8 and 22 for a total of four 28-day cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0803-907 | OTHER | OBA | None |
| 105861 | OTHER | None | None |
| RV-MDS-PI-202 | OTHER | None | None |
| BB-IND 13478 | OTHER | None | None |