Completed

Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

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What is being tested

rituximab

Biological
Who is being recruted

Lymphoma

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 2004

See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: February 1, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: January 23, 2004Actual date on which the first participant was enrolled.

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 * 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.

Official TitleRandomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma 
Principal SponsorEastern Cooperative Oncology Group
Last updated: February 1, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
545 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma
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.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
Group II
Experimental
Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
Study Objectives
Primary Objectives

TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
Secondary Objectives

TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.

The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.

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 483 locations
Suspended
Mayo Clinic ScottsdaleScottsdale, United StatesSee the location
Suspended
Hembree Mercy Cancer Center at St. Edward Mercy Medical CenterFort Smith, United States
Suspended
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, United States
Suspended
Providence Saint Joseph Medical Center - BurbankBurbank, United States
Completed483 Study Centers