A Phase II Trial of Lenalidomide (Revlimid (TM), CC-5013) (NSC #703813, IND#70116) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
PRIMARY OBJECTIVES:
I. To determine the response rate (overall and complete) to treatment with lenalidomide and
rituximab in patients with follicular non-Hodgkin lymphoma (NHL) who have received no prior
systemic therapy.
II. To determine the time to progression after treatment with lenalidomide and rituximab in
patients with previously untreated CD20+ follicular NHL.
SECONDARY OBJECTIVES:
I. To determine the toxicity profile of this regimen in patients with previously untreated
CD20+ follicular NHL.
II. To establish whether the therapeutic effects of this regimen are sufficiently promising
to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
III. To correlate Fcγ receptor polymorphism profiling with response to treatment with this
regimen in patients with previously untreated follicular NHL.
IV. To determine the impact of lenalidomide on immune parameters in patients with previously
untreated follicular NHL.
V. To determine the impact of lenalidomide on angiogenic parameters in patients with
previously untreated follicular NHL.
VI. To correlate lymphoma-associated macrophages (LAM) and FOXP3, GzB, CD10, MUM1, and BCL2
expression with response to treatment with this regimen in patients with previously
untreated follicular NHL.
VII. To determine whether immune gene signatures previously identified as prognostic factors
in follicular lymphoma can be applied to paraffin-embedded tissues in patients treated with
rituximab, to evaluate microRNA signatures associated with these gene signatures and
outcome, to validate immunohistochemical markers associated with outcome in follicular
lymphoma (CD68 LAMs, FOXP3, CD10, BCL6, FOXP1, MUM1), and to investigate whether markers of
angiogenesis may be of value in the prognosis of follicular NHL.
OUTLINE: This is a multicenter study.
Patients receive oral lenalidomide once daily on days 1-21. Treatment with lenalidomide
repeats every 28 days for 12 courses in the absence of disease progression or unacceptable
toxicity. Patients also receive rituximab IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the
absence of disease progression or unacceptable toxicity.
Blood, plasma, and tissue samples may be collected periodically for correlative studies.
After completion of study treatment, patients are followed up every 4 months for 2 years and
then every 6 months for up to 8 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
The true CR rate and its 95% confidence interval will be estimated for each risk group.
At 12 months
No
Peter Martin
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2011-02047
NCT01145495
June 2010
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
North Shore University Hospital | Manhasset, New York 11030 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Weill Medical College of Cornell University | New York, New York 10021 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Great Plains Regional Medical Center | North Platte, Nebraska 69101-6598 |
Mountainview Medical | Berlin, Vermont 05602 |
Eureka Hospital | Eureka, Illinois 61530 |
Graham Hospital Association | Canton, Illinois 61520 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Center for Cancer Care and Research | St. Louis, Missouri 63141 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Harold Alfond Center for Cancer Care | Augusta, Maine 04330 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Saint Francis Medical Center | Grand Island, Nebraska 68802 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Glens Falls Hospital | Glens Falls, New York 12801 |
University Of Vermont | Burlington,, Vermont 05403 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Southeast Cancer Center | Cape Girardeau, Missouri 63703 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Hematology Oncology Associates-Quad Cities | Bettendorf, Iowa 52722 |
Missouri Baptist Medical Center | Saint Louis, Missouri 63131 |
Exeter Hospital | Exeter, New Hampshire 03833 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
University of Illinois | Chicago, Illinois 60612 |
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-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 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Moses Cone Health System-Regional Cancer Center | Greensboro, North Carolina 27403 |
East Carolina University | Greenville, North Carolina 27858 |
Annie Penn Memorial Hospital | Reidsville, North Carolina 27320 |
Monter Cancer Center | Lake Success, New York 11042 |
Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City, Missouri 65109 |
Comprehensive Cancer Care PC | Saint Louis, Missouri 63141 |
Walter Reed National Military Medical Center | Bethesda, Maryland 20889 |
Cancer and Leukemia Group B | Chicago, Illinois 60606 |
North Shore-LIJ Health System CCOP | Manhasset, New York 11030 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |