Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of the Combination of Lenalidomide and Rituximab in Patients With Relapsed/Refractory Follicular NHL (RV 0163)|
- Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.
- Time to disease progression [ Time Frame: Up to two years ] [ Designated as safety issue: No ]Time to progression will be measured as the time from when the patient started treatment to the time the patient is first recorded as having disease progression, or the date of death if the patient dies due to causes other than disease progression
- Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0) [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: Up to two years ] [ Designated as safety issue: No ]
The duration of response is measured from the time measurement criteria are met for complete response/partial response(whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
The duration of response is measured from the time measurement criteria are first met for complete response until the first date that recurrent disease is objectively documented.
- Overall survival [ Time Frame: Up to two years ] [ Designated as safety issue: No ]Overall survival wil be measured as the time from start of treatment to the date of death or the last date the patient was known to be alive
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide and Rituximab
Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
Injection for Intravenous Use, 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15.
Other Name: Rituxan, MabTheraDrug: Lenalidomide
Supplied as 5mg capsules; Dosage: 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.
Other Name: REVLIMID
- To determine the response rate in patients with relapsed or refractory follicular or small lymphocytic non-Hodgkin lymphoma treated with lenalidomide and rituximab.
- 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.
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Joseph M. Tuscano, MD||University of California, Davis|