Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and comparing them to see how well they work in treating patients with low tumor burden indolent stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
To compare the time to first cytotoxic therapy between the rituximab scheduled and rituximab retreatment arms.
To document the rationale for beginning cytotoxic therapy; defined as chemotherapy, radiation therapy or radioimmunotherapy.
To compare the toxicities associated with rituximab therapy between the two randomized treatment arms.
Quality of Life Objectives:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histologic subtype (follicular vs other), age (under 60 vs 60 and over), and the time from diagnosis (less than 1 year vs at least 1 year).
Patients are re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab are randomized to 1 of 2 treatment arms.
Quality of life is assessed after induction rituximab treatment and at 26, 39, 65, 117, 169, and 221 weeks after randomization.
Patients are followed at least annually for 15 years from study entry.
INCLUSION CRITERIA:
Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:
Stage III or IV disease
Must meet the following criteria for low tumor burden:
No nodal or extranodal mass at least 7 cm
Less than 3 nodal masses greater than 3 cm in diameter
No systemic symptoms or B symptoms
No splenomegaly greater than 16 cm by a computed tomography (CT) scan
No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)
No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes
No cytopenias, defined as any of the following:
At least 1 objective measurable disease parameter
Age: 18 and over
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Must meet the following criteria for labs:
Hematopoietic
Hepatic
Renal
EXCLUSION CRITERIA:
Fort Smith, Arkansas 72903, United States
Little Rock, Arkansas 72205, United States
Palm Springs, California 92262, United States
San Francisco, California 94115, United States
Santa Clara, California 95051, United States
South San Francisco, California 94080, United States
Grand Junction, Colorado 81502, United States
Boca Raton, Florida 33486, United States
Fort Lauderdale, Florida 33308, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83712, United States
Chicago, Illinois 60611-3013, United States
Chicago, Illinois 60657, United States
Olympia Fields, Illinois 60461, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Baltimore, Maryland 21231-2410, United States
Largo, Maryland 20774, United States
Rockville, Maryland 20850, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Cape Girardeau, Missouri 63701, United States
Kansas City, Missouri 64154, United States
St Louis, Missouri 63141, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Carson City, Nevada 89703, United States
Englewood, New Jersey 07631, United States
Pomona, New Jersey 08240, United States
Vineland, New Jersey 08360, United States
Voorhees Township, New Jersey 08043, United States
The Bronx, New York 10461, United States
The Bronx, New York 10466, United States
Charlotte, North Carolina 28232-2861, United States
Charlotte, North Carolina 28233-3549, United States
Greenville, North Carolina 27835-6028, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Allentown, Pennsylvania 18105, United States
Drexel Hill, Pennsylvania 19026, United States
DuBois, Pennsylvania 15801, United States
East Stroudsburg, Pennsylvania 18301, United States
Hershey, Pennsylvania 17033-0850, United States
Lemoyne, Pennsylvania 17043, United States
Philadelphia, Pennsylvania 19104-4283, United States
Philadelphia, Pennsylvania 19107-5541, United States
Reading, Pennsylvania 19612-6052, United States
Scranton, Pennsylvania 18510, United States
Upland, Pennsylvania 19013, United States
Wilkes-Barre, Pennsylvania 18711, United States
Williamsport, Pennsylvania 17701, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Huntington, West Virginia 25701, United States
Eau Claire, Wisconsin 54701, United States
Elkhorn, Wisconsin 53121, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
La Crosse, Wisconsin 54601, United States
Madison, Wisconsin 53792-6164, United States
Manitowoc, Wisconsin 54221-1450, United States
Wausau, Wisconsin 54401, United States