Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474188
Status:
TERMINATED
Last Update Posted:
2009-09-02
First Post:
2007-05-14
Brief Title:
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell 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 Lenalidomide Revlimid in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Status:
TERMINATED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of lenalidomide Revlimid in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma
Detailed Description:
Non-Hodgkins lymphoma NHL can be divided into two general prognostic groups the indolent lymphomas and the aggressive lymphomas Indolent lymphomas have a relatively good prognosis with median survival time as long as 10 years but they are not usually curable in advanced stages Aggressive NHL constitutes about half of all cases of NHL in North America and Western Europe Of the aggressive lymphomas diffuse large B-cell lymphoma DLBCL is the most common type accounting for up to 30 percent of newly diagnosed cases The aggressive type of NHL has a shorter natural history approximately 50-60 of these subjects can be cured with combination chemotherapy regimens Even with recent advances many patients with advanced stage DLBCL are not cured with conventional therapy This leaves a subset of subjects who will eventually relapse or who are refractory to treatment
Due to the variation in the clinical behavior of the different types of aggressive NHL it is important to test lenalidomide in DLBCL Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas as well as in indolent NHL It is important to test lenalidomide in combination therapy This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone
Due to the variation in the clinical behavior of the different types of aggressive NHL it is important to test lenalidomide in DLBCL Other studies are addressing the activity of lenalidomide in the other types of aggressive lymphomas as well as in indolent NHL It is important to test lenalidomide in combination therapy This study is focused on treating subjects with relapsed or refractory DLBCL using oral lenalidomide in combination with oral dexamethasone
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