A Phase II Trial of Ofatumumab (CALGB IND #) in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
- To determine the response rate in patients with previously untreated CD20-positive
bulky stage II, or stage III or IV follicular non-Hodgkin lymphoma (NHL) treated with a
lower- or high-dose of ofatumumab.
- To determine the progression-free survival (PFS) of patients treated with these
- To determine the toxicity profile of these regimens in these patients.
- To establish whether the therapeutic effect of single-agent ofatumumab is sufficiently
promising to warrant evaluation in subsequent randomized, ofatumumab-based, biologic
- To evaluate the two ofatumumab doses by independent comparison of response, PFS, and
toxicity to a historical control in previously untreated patients with follicular NHL.
- To prospectively validate the FLIPI2 prognostic index in low- and intermediate-risk
patients and compare to low- and intermediate-risk stratified patients by standard
FLIPI scoring to determine a more reliable indicator of response and PFS.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive high-dose ofatumumab IV over 2-8 hours on days 1, 8, 15, and 22
and then once monthly in months 3-9.
- Arm II: Patients receive a lower dose of ofatumumab IV over 2-8 hours on days 1, 8, 15,
and 22 and then once monthly in months 3-9.
In both arms, treatment continues in the absence of disease progression or unacceptable
Patients may undergo blood and bone marrow sample collection for correlative studies.
After completion of study therapy, patients are followed up every 4 months for 2 years and
then every 6 months for 8 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response (complete or partial response)
Cara A. Rosenbaum, MD
University of Chicago
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|Methodist Medical Center of Illinois||Peoria, Illinois 61636|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|Long Island Jewish Medical Center||New Hyde Park, New York 11040|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Battle Creek Health System Cancer Care Center||Battle Creek, Michigan 49017|
|Munson Medical Center||Traverse City, Michigan 49684|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|Butterworth Hospital at Spectrum Health||Grand Rapids, Michigan 49503-2560|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Don Monti Comprehensive Cancer Center at North Shore University Hospital||Manhasset, New York 11030|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Eureka Community Hospital||Eureka, Illinois 61530|
|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|
|Mecosta County Medical Center||Big Rapids, Michigan 49307|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Monter Cancer Center of the North Shore-LIJ Health System||Lake Success, New York 11042|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||Columbus, Ohio 43210-1240|
|Union Hospital of Cecil County||Elkton MD, Maryland 21921|
|Kinston Medical Specialists||Kinston, North Carolina 28501|
|Lacks Cancer Center at Saint Mary's Health Care||Grand Rapids, Michigan 49503|
|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 - Eureka||Eureka, Illinois 61530|
|Illinois CancerCare - Macomb||Macomb, Illinois 61455|
|Illinois CancerCare - Community Cancer Center||Normal, Illinois 61761|
|Illinois CancerCare - Pekin||Pekin, Illinois 61603|
|Illinois CancerCare - Peru||Peru, Illinois 61354|
|Illinois CancerCare - Spring Valley||Spring Valley, Illinois 61362|
|Iowa Blood and Cancer Care||Cedar Rapids, Iowa 52402|
|Mercy General Health Partners||Muskegon, Michigan 49443|
|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|
|Cleveland Clinic Florida - Weston||Weston, Florida 33331|
|Spectrum Health Reed City Hospital||Reed City, Michigan 49677|
|Mount Kisco Medical Group, PC||Mount Kisco, New York 10549|