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NCT00112931 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2024-05-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Watch and Wait - no treatment
    intervention Names
    1. Other: No treatment
    label
    Watch and Wait
    type
    ACTIVE_COMPARATOR
  2. description
    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
    intervention Names
    1. Biological: rituximab
    label
    Arm C Rituximab 4 and Rixuximab Maintenance
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm C Rituximab 4 and Rixuximab Maintenance
    name
    rituximab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Watch and Wait
    name
    No treatment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
462
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    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 Outcomes
  1. measure
    Frequency of clinical spontaneous remission
    time Frame
    From randomisation until the initiation of chemotherapy in the watch and wait arm
  2. measure
    Cause specific survival
    time Frame
    Time from randomisation to death from lymphoma or immediate therapy related toxicity
  3. measure
    Overall survival
    time Frame
    Time from randomisation to death from any cause.
  4. measure
    Response rate at 25 months
    time Frame
    Response at 25 months
Full study description
brief Summary
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.
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.
Source references
references
  1. citation
    Northend M, Wilson W, Ediriwickrema K, Clifton-Hadley L, Qian W, Rana Z, Martin TL, Townsend W, Young M, Miall F, Cunningham D, Walewski J, Ferhanoglu B, Linton K, Johnston A, Seymour JF, Linch DC, Ardeshna KM. Early rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumour burden follicular lymphoma: long-term results of a randomised, phase 3 trial. Lancet Haematol. 2025 May;12(5):e335-e345. doi: 10.1016/S2352-3026(25)00034-1.
    pmid
    40306831
    type
    DERIVED
  2. citation
    Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, Warden J, Stevens L, Pocock CF, Miall F, Cunningham D, Davies J, Jack A, Stephens R, Walewski J, Ferhanoglu B, Bradstock K, Linch DC. Rituximab versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014 Apr;15(4):424-35. doi: 10.1016/S1470-2045(14)70027-0. Epub 2014 Mar 4.
    pmid
    24602760
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        on (4.1 years) (HR, 0.61; 95% CI, 0.52&#8722;0.73; <em>P</em> &lt; .001), but with no difference in OS.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT00112931">United Kingdom/International Study</a> (NCT00112931), 379 previously untreated patients with asymptomatic, low-burden disease were randomly assigned to watchf
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        m>P</em> &lt; .001), but with no difference in OS.</li></ul></div></li><li>In the <a href="/clinicaltrials/NCT00112931">United Kingdom/International Study</a> (NCT00112931), 379 previously untreated patients with asymptomatic, low-burden disease were randomly assigned to watchful waiting versus rituximab induction only versus rit
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      source title
      Indolent B-Cell Non-Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice