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AzTrials

LymphomaPhase 3NCT00112931

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

A Phase 3 study testing rituximab and No treatment in people with Lymphoma, run by University College, London at 72 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab and No treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
462 participants
Where
72 sitesin 3 countries
Study dates
Sep 2004to 14 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

72 sites in 3 countries.

72 sites in 3 countries

United Kingdom42 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Monklands General Hospital

    Airdrie, Scotland, ML6 0JF

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • West Suffolk Hospital

    Bury St Edmunds, England, IP33 2QZ

  • Kent and Canterbury Hospital

    Canterbury, England, CT1 3NG

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • St. Helier Hospital

    Carshalton, England, SM5 1AA

  • Hairmyres Hospital

    East Kilbride, Scotland, G75 8RG

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • Medway Maritime Hospital

    Gillingham, England, ME7 5NY

  • Southern General Hospital

    Glasgow, Scotland, G51 4TF

  • Hemel Hempstead General

    Hemel Hempstead, England, HP2 4AD

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • West Middlesex University Hospital

    Isleworth, England, TW7 6AF

  • Kettering General Hosptial

    Kettering, England, NNI6 8UZ

  • Kidderminster Hospital

    Kidderminster, England, DY11 6RJ

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • St. George's Hospital

    London, England, SW17 0QT

  • Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Prince Charles Hospital

    Merthyr Tydfil, Wales, CF47 9DT

  • Sir James Spence Institute of Child Health at Royal Victoria Infirmary

    Newcastle upon Tyne, England, NE1 4LP

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Royal Alexandra Hospital

    Paisley, Scotland

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Alexandra Healthcare NHS

    Redditch, England, B98 7UB

  • Glan Clwyd Hospital

    Rhyl, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Pembury Hospital

    Royal Tunbridge Wells, England, TN2 4QJ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • South West Wales Cancer Institute

    Swansea, Wales, SA2 8QA

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, England, TR1 3LJ

  • Weston General Hospital

    Weston-super-Mare, England, BS23 4TQ

  • Wishaw General Hospital

    Wishaw, Scotland, ML2 0DP

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

Other trials in United Kingdom

Australia26 sites

  • Queen Elizabeth Hospital

    Adelaide

  • Royal Adelaide Hospital

    Adelaide

  • Ashford Cancer Centre

    Black Forest

  • Boxhill Hospital

    Box Hill

  • Royal Brisbane and Women's Hospital

    Brisbane

  • Canberra Hospital

    Canberra

  • Concord Repatriation General Hospital

    Concord

  • Frankston Hospital

    Frankston

  • Fremantle Hospital

    Fremantle

  • Gosford Hospital

    Gosford

  • Royal Hobart Hospital

    Hobart

  • Nepean Hospital

    Kingswood

  • Lismore Base Hospital

    Lismore

  • Liverpool Hospital

    Liverpool

  • Alfred Hospital

    Melbourne

  • Austin Health

    Melbourne

  • Peter MacCallum Cancer Centre

    Melbourne

  • St Vincent's Hospital

    Melbourne

  • Mater Misericordiae Hospital

    Newcastle

  • Royal Perth Hospital

    Perth

  • Royal North Shore Hospital

    St Leonards

  • St Vincent's Hospital

    Sydney

  • Westmead Hospital

    Westmead

  • Murray Valley Private Hospital

    Wodonga

  • Wollongong Hospital

    Wollongong

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

New Zealand4 sites

  • Auckland Hospital

    Auckland

  • Middlemore Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

  • North Shore Hospital

    Westlake

Other trials in New Zealand

About this study

Official title: An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma

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.

Read the 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.

Conditions
Lymphoma
Being tested
rituximab, No treatment
Keywords
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
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00112931
Study groupRoleWhat they receive
Watch and WaitActive comparatorWatch and Wait - no treatment
Receives: Other: No treatment
Arm C Rituximab 4 and Rixuximab MaintenanceExperimental4 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
Receives: Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time until initiation of therapy (chemotherapy or radiotherapy)

    Measured: 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 (4)

  1. Frequency of clinical spontaneous remission

    Measured: From randomisation until the initiation of chemotherapy in the watch and wait arm

  2. Cause specific survival

    Measured: Time from randomisation to death from lymphoma or immediate therapy related toxicity

  3. Overall survival

    Measured: Time from randomisation to death from any cause.

  4. Response rate at 25 months

    Measured: Response at 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2005 (estimated)
  2. Study startSep 2004
  3. Primary completionMar 2014
  4. Study completion14 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
462 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00112931
Sponsor's protocol ID
CDR0000427312
Other IDs
CRUK-2004-001621-16, EU-20509, ROCHE-CRUK-001621-16
Status last verified
May 2024
First submitted
2 Jun 2005
Last updated
9 May 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40306831

  • 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.

    PubMed 24602760

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab and No treatment in people with Lymphoma, run by University College, London at 72 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00112931, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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