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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Eastern Cooperative Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00075946
First received: January 12, 2004
Last updated: February 11, 2014
Last verified: October 2008

January 12, 2004
February 11, 2014
November 2003
September 2013   (final data collection date for primary outcome measure)
Time to treatment failure [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00075946 on ClinicalTrials.gov Archive Site
Time to first cytotoxic therapy [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Rituximab in Treating 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

  • Compare the time to rituximab failure in patients with low tumor burden indolent non-Hodgkin's lymphoma treated with rituximab scheduled vs rituximab retreatment.

Secondary

  • Compare the time to first cytotoxic therapy in patients treated with these regimens.
  • Determine the rationale for beginning cytotoxic therapy, defined as chemotherapy, radiotherapy, or radioimmunotherapy, in patients treated with these regimens.
  • Compare the toxic effects associated with these regimens in these patients.
  • Correlate response and duration of response in these patients with rituximab pharmacokinetics.
  • Compare the health-related quality of life, distress, psychological functioning, physical well-being, and functional well-being of patients treated with these regimens.
  • Compare the impact of differential treatment response (delayed time to rituximab failure and/or time to first cytotoxic therapy) on quality of life, distress, and psychological functioning in patients treated with these regimens.
  • Determine, prospectively, the physical and functional well-being of patients during treatment with these regimens.

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 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 I (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 II (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.

PROJECTED ACCRUAL: A total of 389 patients will be accrued for this study within 45 months.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lymphoma
Biological: rituximab
Given IV
  • Active Comparator: Arm I
    Patients receive rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
    Intervention: Biological: rituximab
  • Experimental: Arm II
    Patients receive a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
    Intervention: Biological: rituximab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
389
Not Provided
September 2013   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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)
  • No evidence of transformation to a large cell histology
  • 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 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 PET scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • 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
  • AST/ALT no greater than 5 times ULN
  • Hepatitis B surface antigen negative

Renal

  • Creatinine no greater than 2 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No uncontrolled active infection

    • Afebrile for at least 48 hours off antibiotics
  • No 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 CONCURRENT THERAPY:

Biologic therapy

  • See Radiotherapy
  • No prior immunotherapy for lymphoma

Chemotherapy

  • No prior chemotherapy for lymphoma
  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for lymphoma
  • No concurrent radiotherapy
  • No concurrent radioimmunotherapy

Surgery

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00075946
CDR0000346359, U10CA021115, ECOG-E4402
Not Provided
Robert L. Comis, ECOG Group Chair's Office
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Brad S. Kahl, MD University of Wisconsin, Madison
Eastern Cooperative Oncology Group
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP