Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
- Registration Number
- NCT00238238
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.
- Detailed Description
Outline:
This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary objectives of the study are provided below.
Primary Objectives:
* To determine the response rate (overall and complete) after lenalidomide therapy and rituximab + lenalidomide in follicular NHL patients who have relapsed.
* To determine time to progression after lenalidomide therapy and rituximab and lenalidomide in follicular NHL patients who have relapsed.
Secondary Objectives:
* To compare the time to progression of the previous rituximab regimen to that obtained subsequently to lenalidomide therapy and rituximab + lenalidomide.
* To determine the toxicity profile of lenalidomide therapy and of rituximab and lenalidomide in follicular NHL patients who have received a previous rituximab regimen.
* To correlate Fc receptor polymorphism profiling with response to lenalidomide or rituximab + lenalidomide in previously treated patients with follicular NHL who have relapsed.
* To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells and several plasma cytokines followed by rituximab therapy and correlation of observed changes to objective response rates.
After completion of study treatment, patients are followed for up to 10 years from study entry.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I - rituximab rituximab Patients receive rituximab IV on days 1, 8, 15, and 22. Arm III - lenalidomide and rituximab rituximab Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29. Arm III - lenalidomide and rituximab lenalidomide Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29. Arm II - lenalidomide lenalidomide Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Overall Response Rate Duration of treatment (12 cycles) Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a \>/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Time to Progression Up to 10 years Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Illinois CancerCare - Galesburg
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare - Havana
🇺🇸Havana, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Illinois CancerCare - Macomb
🇺🇸Macomb, Illinois, United States
Illinois CancerCare - Kewanee Clinic
🇺🇸Kewanee, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Illinois CancerCare - Pekin
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Illinois CancerCare - Peru
🇺🇸Peru, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Illinois CancerCare - Princeton
🇺🇸Princeton, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois CancerCare - Spring Valley
🇺🇸Spring Valley, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Saint Luke's Cancer Institute at Saint Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Heartland Hematology Oncology Associates, Incorporated
🇺🇸Kansas City, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Cancer Centers of the Carolinas - Grove Commons
🇺🇸Greenville, South Carolina, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
🇺🇸Concord, New Hampshire, United States
New Hampshire Oncology - Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Lakes Region General Hospital
🇺🇸Laconia, New Hampshire, United States
Cancer Centers of the Carolinas - Easley
🇺🇸Easley, South Carolina, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
🇺🇸Greenville, South Carolina, United States
Greenville Hospital Cancer Center
🇺🇸Greenville, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Self Regional Cancer Center at Self Regional Medical Center
🇺🇸Greenwood, South Carolina, United States
Cancer Centers of the Carolinas - Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Cancer Centers of the Carolinas - Seneca
🇺🇸Seneca, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Mountainview Medical
🇺🇸Berlin, Vermont, United States
Kaiser Permanente Medical Office -Vandever Medical Office
🇺🇸San Diego, California, United States
Illinois CancerCare - Bloomington
🇺🇸Bloomington%, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Illinois CancerCare - Canton
🇺🇸Canton, Illinois, United States
Illinois CancerCare - Carthage
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Illinois CancerCare - Eureka
🇺🇸Eureka, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Illinois CancerCare - Monmouth
🇺🇸Monmouth, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Illinois CancerCare - Community Cancer Center
🇺🇸Normal, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
St. Joseph Medical Center
🇺🇸Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Liberty Hospital
🇺🇸Liberty, Missouri, United States
Saint Joseph Oncology, Incorporated
🇺🇸Saint Joseph, Missouri, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Saint Luke's Hospital - South
🇺🇸Overland Park, Kansas, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States