Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 9:40 AM
Study NCT ID:
NCT00848328
Status:
TERMINATED
Last Update Posted:
2025-04-24
First Post:
2009-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)
Status:
TERMINATED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.
Detailed Description:
OBJECTIVES:
Primary
* To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.
Secondary
* To determine the time to disease progression, duration of response, and overall survival of these patients.
* To determine the tolerability of this regimen in these patients.
* To assess changes in serum cytokines before and after treatment and correlate these changes with response.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not achieve complete response after 2 courses of rituximab may receive up to 4 additional doses of rituximab once weekly for 4 weeks.
Blood samples are collected at baseline and after treatment for cytokine analysis.
After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.
Primary
* To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.
Secondary
* To determine the time to disease progression, duration of response, and overall survival of these patients.
* To determine the tolerability of this regimen in these patients.
* To assess changes in serum cytokines before and after treatment and correlate these changes with response.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 15 and 22 of course 1 and on days 1 and 8 of course 2. Patients who do not achieve complete response after 2 courses of rituximab may receive up to 4 additional doses of rituximab once weekly for 4 weeks.
Blood samples are collected at baseline and after treatment for cytokine analysis.
After completion of study treatment, patients are followed at 30 days and then every 3 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?: