A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Diffuse Large B-cell Lymphoma
Drug: CC-5013 (lenalidomide)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Tumor Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Tumor Control Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: One year ] [ Designated as safety issue: No ]
- Time to Progression [ Time Frame: One year ] [ Designated as safety issue: No ]
- Progression-free Survival [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|Experimental: Single Arm||
Drug: CC-5013 (lenalidomide)
Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle
Other Names:Drug: dexamethasone
Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.
Other Name: Decadron
Non-Hodgkin's 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.
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|Principal Investigator:||Andrew Spencer, MD||The Alfred Hospital|