Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01282476
Status:
TERMINATED
Last Update Posted:
2017-05-09
First Post:
2011-01-21
Brief Title:
Panobinostat With Rituximab for RelapsedRefractory Diffuse Large B Cell Lymphoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Panobinostat in Combination With Rituximab For RelapsedRefractory Diffuse Large B Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes Panobinostat has shown effects against cancer in laboratory studies However it is not known if it will show the same activity in humans Panobinostat has been given to participants with various types of cancers including DLBCL in previous research studies In this study panobinostat will be given with the the antibody rituximab which is FDA approved to be given with chemotherapy in DLBCL
Detailed Description:
Study treatment will be given in 4 week periods called cycles Panobinostat will be taken orally on Monday Wednesday and Friday of each week Rituximab will be given as an intravenous infusion weekly during Cycle 1 and then once per month on day 1 of subsequent cycles Subjects can receive up to 6 cycles of treatment Blood draws and 2 EKGs electrocardiograms will be done weekly in Cycle 1 and then once in each cycle PETCT Positron Emission TomographyComputed Tomography scans will be done every 2 months
If disease has not progressed after 6 cycles on combination of panobinostat and rituximab subjects may continue on panobinostat alone for up to 6 additional months
If disease has not progressed after 6 cycles on combination of panobinostat and rituximab subjects may continue on panobinostat alone for up to 6 additional months
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