Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome.
Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma.
The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma.
Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well.
Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab.
Blood samples will be collected to assess how the immune system is functioning.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non Hodgkin's Lymphoma|
- Response rate to treatment [ Time Frame: 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.
- Time to progression [ Time Frame: 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 [ Time Frame: 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
- Tolerability [ Time Frame: Up to two years. ]Tolerability means the type, frequency, severity and relationship of adverse events to study treatment based on the National Cancer Institute Common Toxicity Criteria Version 4.0
- Duration of response from start of therapy [ Time Frame: 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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide + Rituximab
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Other Name: RituxanDrug: Lenalidomide
Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
Other Name: Revlimid
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316523
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Sutter Pacific Medical Foundation|
|Santa Rosa, California, United States, 95403|
|Principal Investigator:||Joseph Tuscano, MD||University of California, Davis|