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)
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
OUTLINE:
- 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate
10 months
No
Barbara W. Grant, MD
Study Chair
University of Vermont
United States: Food and Drug Administration
CDR0000572604
NCT00553501
March 2008
July 2019
Name | Location |
---|---|
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 |