Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Collaborators:
Cancer Research UK
Roche Pharma AG
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT00112931
First received: June 2, 2005
Last updated: November 14, 2016
Last verified: November 2016
  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: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of clinical spontaneous remission [ Time Frame: From randomisation until the initiation of chemotherapy in the watch and wait arm ] [ Designated as safety issue: No ]
  • Cause specific survival [ Time Frame: Time from randomisation to death from lymphoma or immediate therapy related toxicity ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Time from randomisation to death from any cause. ] [ Designated as safety issue: No ]
  • Response rate at 25 months [ Time Frame: Response at 25 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112931

Locations
United Kingdom
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
West Suffolk Hospital
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
St. Helier Hospital
Carshalton, England, United Kingdom, SM5 1AA
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Queen Elizabeth Hospital
Gateshead-Tyne and Wear, England, United Kingdom, NE9 6SX
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom, ME7 5NY
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom, HP2 4AD
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
West Middlesex University Hospital
Isleworth, England, United Kingdom, TW7 6AF
Kettering General Hosptial
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
Queen Elizabeth Hospital
King's Lynn, England, United Kingdom, PE30 4ET
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
Alexandra Healthcare NHS
Redditch, Worcestershire, England, United Kingdom, B98 7UB
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom, TN2 4QJ
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Weston General Hospital
Weston-super-Mare, England, United Kingdom, BS23 4TQ
Worcester Royal Hospital
Worcester, England, United Kingdom, WR5 1DD
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Monklands General Hospital
Airdrie, Scotland, United Kingdom, ML6 0JF
Hairmyres Hospital
East Kilbride, Scotland, United Kingdom, G75 8RG
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Wishaw General Hospital
Wishaw, Scotland, United Kingdom, ML2 0DP
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Prince Charles Hospital
Mid Glamorgan, Wales, United Kingdom, CF47 9DT
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
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 
Study First Received: June 2, 2005
Last Updated: November 14, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 09, 2016