A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
- To determine the response rate (overall and complete) after extended induction therapy
comprising epratuzumab and rituximab in patients with previously untreated CD20+
follicular non-Hodgkin lymphoma (NHL).
- To determine the time to progression after extended induction therapy comprising
epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.
- To determine the toxicity profile of epratuzumab and rituximab in patients with
previously untreated CD20+ follicular NHL.
- To establish whether the therapeutic effects of the combination of epratuzumab and
rituximab are sufficiently promising to warrant evaluation in a subsequent randomized
trial (in comparison to rituximab alone).
- To determine the relationship between the change in fludeoxyglucose F 18 uptake early
after epratuzumab and rituximab treatment with response rate and time to progression.
- Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days
1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease
progression or unacceptable toxicity.
- Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV
over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence
of disease progression or unacceptable toxicity.
Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission
tomography at baseline and after induction therapy to assess the degree of FDG uptake.
After completion of study treatment, patients are followed every 4 months for 2 years then
every 6 months for up to 10 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Barbara W. Grant, MD
University of Vermont
United States: Food and Drug Administration
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Ellis Fischel Cancer Center at University of Missouri - Columbia||Columbia, Missouri 65203|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|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|
|Hematology Oncology Associates of the Quad Cities||Bettendorf, Iowa 52722|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|University of Illinois Cancer Center||Chicago, Illinois 60612-7243|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Virginia Commonwealth University Massey Cancer Center||Richmond, Virginia 23298-0037|
|Elkhart General Hospital||Elkhart, Indiana 46515|
|Howard Community Hospital||Kokomo, Indiana 46904|
|South Bend Clinic||South Bend, Indiana 46617|
|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Kaiser Permanente Medical Office -Vandever Medical Office||San Diego, California 92120|
|Fort Wayne Medical Oncology and Hematology||Fort Wayne, Indiana 46815|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Iredell Memorial Hospital||Statesville, North Carolina 28677|
|Mountainview Medical||Berlin, Vermont 05602|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Middlesex Hospital Cancer Center||Middletown, Connecticut 06457|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Union Hospital Cancer Program at Union Hospital||Elkton MD, Maryland 21921|
|Dana-Farber/Brigham and Women's Cancer Center||Boston, Massachusetts 02115|
|Kinston Medical Specialists||Kinston, North Carolina 28501|
|Lakes Region General Hospital||Laconia, New Hampshire 03246|
|Oncology Care Associates, PLLC||Saint Joseph, Michigan 49085|
|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|
|St. Mary's Regional Cancer Center at St. Mary's Medical Center||Huntington, West Virginia 25702|
|Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County||Martinsville, Virginia 24115|