A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (overall and complete) at 2, 4, 6, 9, 12, 15, 18, and 24 months, and then yearly for up to 10 years
Up to 10 years
No
John P. Leonard, MD
Study Chair
Weill Medical College of Cornell University
United States: Food and Drug Administration
CDR0000442872
NCT00238238
March 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Graham Hospital | Canton, Illinois 61520 |
Memorial Hospital | Carthage, Illinois 62321 |
Eureka Community Hospital | Eureka, Illinois 61530 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Community Cancer Center | Normal, Illinois 61761 |
Community Hospital of Ottawa | Ottawa, Illinois 61350 |
Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
Proctor Hospital | Peoria, Illinois 61614 |
Illinois Valley Community Hospital | Peru, Illinois 61354 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Fort Wayne Medical Oncology and Hematology | Fort Wayne, Indiana 46815 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Mountainview Medical | Berlin, Vermont 05602 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Menorah Medical Center | Overland Park, Kansas 66209 |
Saint Luke's Hospital - South | Overland Park, Kansas 66213 |
St. Joseph Medical Center | Kansas City, Missouri 64114 |
Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
North Kansas City Hospital | Kansas City, Missouri 64116 |
Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Liberty Hospital | Liberty, Missouri 64068 |
Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Greenville Hospital Cancer Center | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Grove Commons | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
Cancer Centers of the Carolinas - Greer Medical Oncology | Greer, South Carolina 29650 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Lakes Region General Hospital | Laconia, New Hampshire 03246 |
Galesburg Clinic, PC | Galesburg, Illinois 61401 |
Illinois CancerCare - Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare - Canton | Canton, Illinois 61520 |
Illinois CancerCare - Carthage | Carthage, Illinois 62321 |
Illinois CancerCare - Eureka | Eureka, Illinois 61530 |
Illinois CancerCare - Galesburg | Galesburg, Illinois 61401 |
Illinois CancerCare - Havana | Havana, Illinois 62644 |
Illinois CancerCare - Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare - Macomb | Macomb, Illinois 61455 |
Illinois CancerCare - Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare - Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare - Pekin | Pekin, Illinois 61603 |
Illinois CancerCare - Peru | Peru, Illinois 61354 |
Illinois CancerCare - Princeton | Princeton, Illinois 61356 |
Illinois CancerCare - Spring Valley | Spring Valley, Illinois 61362 |
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord, New Hampshire 03301 |
New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
Cancer Centers of the Carolinas - Easley | Easley, South Carolina 29640 |
Self Regional Cancer Center at Self Regional Medical Center | Greenwood, South Carolina 29646 |