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Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00112931
First Posted: June 3, 2005
Last Update Posted: October 26, 2017
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.
Collaborators:
Cancer Research UK
Roche Pharma AG
Information provided by (Responsible Party):
University College, London
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether rituximab is more effective than observation in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II, stage III, or stage IV follicular non-Hodgkin's lymphoma with no symptoms.


Condition Intervention Phase
Lymphoma Biological: rituximab Other: No treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Time until initiation of therapy (chemotherapy or radiotherapy) [ Time Frame: Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy. ]

Secondary Outcome Measures:
  • Frequency of clinical spontaneous remission [ Time Frame: From randomisation until the initiation of chemotherapy in the watch and wait arm ]
  • Cause specific survival [ Time Frame: Time from randomisation to death from lymphoma or immediate therapy related toxicity ]
  • Overall survival [ Time Frame: Time from randomisation to death from any cause. ]
  • Response rate at 25 months [ Time Frame: Response at 25 months ]

Estimated Enrollment: 600
Study Start Date: September 2004
Estimated Study Completion Date: May 2022
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Watch and Wait
Watch and Wait - no treatment
Other: No treatment
Experimental: Arm C Rituximab 4 and Rixuximab Maintenance
4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks
Biological: rituximab

Detailed Description:

OBJECTIVES:

Primary

  • Compare time to initiation of systemic chemotherapy or radiotherapy in patients with newly diagnosed, previously untreated, asymptomatic stage II-IV non-bulky follicular non-Hodgkin's lymphoma treated with rituximab vs observation only.

Secondary

  • Compare the frequency of clinical spontaneous remission in patients treated with these regimens.
  • Compare overall and cause-specific survival of patients treated with these regimens.
  • Determine the effect of rituximab on complete and partial response in patients treated with subsequent systemic chemotherapy.
  • Compare quality of life, in terms of functional well-being and anxiety and depression, of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, disease grade (1 vs 2 vs 3a), disease stage (II vs III vs IV), and age. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients undergo observation only until disease progression.
  • Arm II: Patients receive induction rituximab IV on day 1. Treatment repeats weekly for up to 4 weeks.
  • Arm III: Patients receive induction rituximab as in arm II. Patients then receive maintenance rituximab IV once on day 1 of weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100.

In all arms, treatment continues in the absence of unacceptable toxicity or disease progression requiring systemic chemotherapy* or radiotherapy.

NOTE: *Rituximab administration in arm I is considered initiation of systemic chemotherapy

Quality of life is assessed at baseline (before and after randomization), every 2 months for 2 years, and then every 6 months for 2 years.

Patients are followed every 2 months for 2 years and then every 3 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 600 patients (200 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular non-Hodgkin's lymphoma

    • Diagnosed within the past 3 months
    • Grade 1, 2, or 3a disease
    • Stage II-IV disease
    • No evidence of histological transformation
  • Bidimensionally measurable disease by clinical examination or radiography
  • Asymptomatic disease without B symptoms or severe pruritus
  • Low tumor burden, defined by all of the following criteria:

    • Lactic dehydrogenase normal
    • Largest nodal or extranodal mass < 7 cm
    • No more than 3 nodal sites with a diameter > 3 cm
    • No clinically detectable significant serous effusion by chest x-ray

      • Clinically non-evident small effusion on CT scan is not considered significant
    • Spleen enlargement ≤ 16 cm by CT scan
  • Circulating tumor cells < 5,000/mm^3
  • No organ compression (i.e., ureteric obstruction)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 10 g/dL

Hepatic

  • AST and ALT normal
  • Alkaline phosphatase normal
  • Bilirubin normal

Renal

  • Creatinine < 2 times upper limit of normal (unless due to lymphoma)

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 12 months after completion of rituximab
  • No known HIV positivity
  • No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No critical organ failure
  • No other immediate life-threatening disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No prior therapy for lymphoma
  Contacts and Locations
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): NCT00112931


  Show 72 Study Locations
Sponsors and Collaborators
University College, London
Cancer Research UK
Roche Pharma AG
Investigators
Study Chair: Kirit Ardeshna Mount Vernon Cancer Centre at Mount Vernon Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT00112931     History of Changes
Other Study ID Numbers: CDR0000427312
CRUK-2004-001621-16
EU-20509
ROCHE-CRUK-001621-16
First Submitted: June 2, 2005
First Posted: June 3, 2005
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University College, London:
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents