Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma
- Registration Number
- NCT00848328
- Lead Sponsor
- University of California, Davis
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenalidomide and Rituximab 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. Lenalidomide and Rituximab Lenalidomide 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.
- Primary Outcome Measures
Name Time Method Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months 4 months 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.
- Secondary Outcome Measures
Name Time Method Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0) Up to two years Time to disease progression Up to two years 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
Overall survival Up to two years 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
Duration of response Up to two years 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.
Trial Locations
- Locations (1)
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States