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Status:

COMPLETED

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

Lead Sponsor:

University College, London

Collaborating Sponsors:

Cancer Research UK

Roche Pharma AG

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE3

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 o...

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-Ho...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 14 2023

    Estimated Enrollment :

    462 Patients enrolled

    Trial Details

    Trial ID

    NCT00112931

    Start Date

    September 1 2004

    End Date

    September 14 2023

    Last Update

    May 9 2024

    Active Locations (72)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 18 (72 locations)

    1

    Queen Elizabeth Hospital

    Adelaide, Australia

    2

    Royal Adelaide Hospital

    Adelaide, Australia

    3

    Ashford Cancer Centre

    Black Forest, Australia

    4

    Boxhill Hospital

    Box Hill, Australia