Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
rituximab
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: January 23, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * To compare time to rituximab failure between the rituximab scheduled and rituximab retreatment arms. 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: 1. To compare health-related quality of life, distress, psychological functioning, physical well-being and functional well-being of patients receiving rituximab scheduled to those receiving rituximab retreatment. 2. To examine the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy), if observed, on quality of life, distress, and psychological functioning on patients receiving rituximab scheduled to those receiving rituximab retreatment. 3. To obtain prospective data on physical and functional well-being during treatment with rituximab. 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). * Induction rituximab: Patients receive rituximab Intravenous (IV) once a week for 4 weeks. 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. * Arm A (retreatment rituximab): Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. * Arm B (scheduled rituximab): Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.545 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: * Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following: * Follicular grade 1 or 2 * Small lymphocytic * Marginal zone (nodal) * Marginal zone (splenic) * Mucosa-associated lymphoid tissue (MALT) * 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: * Platelet count less than 100,000/mm\^3 * Hemoglobin less than 10 g/dL * Absolute neutrophil count less than 1,500/mm\^3 * At least 1 objective measurable disease parameter * Abnormal positron emission tomography (PET) scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging * Age: 18 and over * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Must meet the following criteria for labs: * Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3\* * Hemoglobin at least 10 g/dL\* * Platelet count at least 100,000/mm\^3\* * NOTE: \*Without growth factor and/or transfusion support * Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin normal for patients with Gilbert's Syndrome * The aspartate transaminase (AST) and alanine transaminase (ALT) ratio (AST/ALT) no greater than 5 times ULN * Hepatitis B surface antigen negative * Renal * Creatinine no greater than 2 times ULN EXCLUSION CRITERIA: * Evidence of transformation to a large cell histology * Pregnant or nursing. Fertile patients must use effective contraception * HIV positive * Uncontrolled active infection * Other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Prior immunotherapy for lymphoma * Prior chemotherapy for lymphoma * Concurrent chemotherapy * Prior radiotherapy for lymphoma * Concurrent radiotherapy * Concurrent radioimmunotherapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 480 locations
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, United StatesArkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, United StatesProvidence Saint Joseph Medical Center - Burbank
Burbank, United States