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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00075946
Recruitment Status : Active, not recruiting
First Posted : January 14, 2004
Results First Posted : June 22, 2015
Last Update Posted : June 10, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Actual Study Start Date : November 2003
Actual Primary Completion Date : September 2013
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A: Rituximab Retreatment
Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
 Biological: rituximab
Given IV
Experimental: Arm B: Rituximab Scheduled
Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
 Biological: rituximab
Given IV


Outcome Measures
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Primary Outcome Measures :
  1. Time to Rituximab Failure (TTRF) [ Time Frame: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first. ]
    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 Outcome Measures :
  1. Time to First Cytotoxic Therapy (TTFC) [ Time Frame: Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first. ]
    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.

  2. Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization [ Time Frame: Assessed at baseline and 6 months after randomization. ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075946


Locations
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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Brad S. Kahl, MD University of Wisconsin, Madison
More Information
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Publications of Results:
Kahl BS, Williams ME, Hong F, et al.: Preliminary pharmacokinetic (PK) analysis of Eastern Cooperative Oncology Group Protocol E4402: rituximab extended schedule or re-treatment trial (RESORT) . [Abstract] Blood 110 (11): A-3420, 2007.

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Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00075946    
Other Study ID Numbers: CDR0000346359
U10CA021115 ( U.S. NIH Grant/Contract )
ECOG-E4402 ( Other Identifier: Eastern Cooperative Oncology Group )
First Posted: January 14, 2004    Key Record Dates
Results First Posted: June 22, 2015
Last Update Posted: June 10, 2022
Last Verified: June 2022
Keywords provided by Eastern Cooperative Oncology Group:
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
 stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents