Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179673
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2005-09-10
Brief Title:
Lenalidomide Revlimid CC-5013 in Subjects With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Phase II Multicenter Single-Arm Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide Revlimid CC-5013 in Participants With Relapsed or Refractory Indolent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-11
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:
Participants who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle Treatment will continue for up to 52 weeks or until disease progression participants who achieve a complete response CR will receive an additional 2 cycles of treatment prior to discontinuation Participants will be followed for progression free survival following discontinuation from the treatment phase
Detailed Description:
Participants who qualified for enrollment into the study entered the treatment phase and received single-agent lenalidomide 25 mg once daily on Days 1 to 21 of every 28-day cycle The treatment phase began on Day 1 of Cycle 1 Study visits were scheduled to occur every 28 days to coincide with the beginning of a new cycle The start date of a new cycle was delayed if adverse events AEs occurred in which case the visit date for the start of the following cycle was scheduled 28 days after the actual start date of the delayed cycle Efficacy and safety assessments including complete blood counts CBCs were performed at least every 2 weeks during Cycles 1 to 4 of the treatment phase Participants continued in the treatment phase of the study for up to 52 weeks or until disease progression developed lenalidomide treatment was discontinued for any reason or the study was terminated
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