Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
NCT ID: NCT00112931
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
462 participants
INTERVENTIONAL
2004-09-30
2023-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
NCT01145495
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
NCT00227695
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
NCT01856192
Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma
NCT01829568
Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma
NCT00440388
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Watch and Wait
Watch and Wait - no treatment
No treatment
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
rituximab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rituximab
No treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Research UK
OTHER
Roche Pharma AG
INDUSTRY
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kirit Ardeshna
Role: STUDY_CHAIR
Mount Vernon Cancer Centre at Mount Vernon Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Queen Elizabeth Hospital
Adelaide, , Australia
Royal Adelaide Hospital
Adelaide, , Australia
Ashford Cancer Centre
Black Forest, , Australia
Boxhill Hospital
Box Hill, , Australia
Royal Brisbane and Women's Hospital
Brisbane, , Australia
Canberra Hospital
Canberra, , Australia
Concord Repatriation General Hospital
Concord, , Australia
Frankston Hospital
Frankston, , Australia
Fremantle Hospital
Fremantle, , Australia
Gosford Hospital
Gosford, , Australia
Royal Hobart Hospital
Hobart, , Australia
Nepean Hospital
Kingswood, , Australia
Lismore Base Hospital
Lismore, , Australia
Liverpool Hospital
Liverpool, , Australia
Alfred Hospital
Melbourne, , Australia
Austin Health
Melbourne, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
St Vincent's Hospital
Melbourne, , Australia
Mater Misericordiae Hospital
Newcastle, , Australia
Royal Perth Hospital
Perth, , Australia
Royal North Shore Hospital
St Leonards, , Australia
St Vincent's Hospital
Sydney, , Australia
Westmead Hospital
Westmead, , Australia
Murray Valley Private Hospital
Wodonga, , Australia
Wollongong Hospital
Wollongong, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Auckland Hospital
Auckland, , New Zealand
Middlemore Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
North Shore Hospital
Westlake, , New Zealand
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
West Suffolk Hospital
Bury St Edmunds, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
St. Helier Hospital
Carshalton, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Medway Maritime Hospital
Gillingham, England, United Kingdom
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
West Middlesex University Hospital
Isleworth, England, United Kingdom
Kettering General Hosptial
Kettering, England, United Kingdom
Kidderminster Hospital
Kidderminster, England, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
St. George's Hospital
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Alexandra Healthcare NHS
Redditch, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Pembury Hospital
Royal Tunbridge Wells, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Torbay Hospital
Torquay, England, United Kingdom
Royal Cornwall Hospital
Truro, England, United Kingdom
Weston General Hospital
Weston-super-Mare, England, United Kingdom
Worcester Royal Hospital
Worcester, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Hairmyres Hospital
East Kilbride, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Southern General Hospital
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Wishaw General Hospital
Wishaw, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Prince Charles Hospital
Merthyr Tydfil, Wales, United Kingdom
Glan Clwyd Hospital
Rhyl, Wales, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRUK-2004-001621-16
Identifier Type: -
Identifier Source: secondary_id
EU-20509
Identifier Type: -
Identifier Source: secondary_id
ROCHE-CRUK-001621-16
Identifier Type: -
Identifier Source: secondary_id
CDR0000427312
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.