Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Alternate Title
Basic Trial Information
Trial Description
Purpose
Eligibility
Treatment/Intervention
Trial Contact Information
Registry Information
Alternate Title
Phase III Randomized Study of Rituximab Versus Observation Only in Patients With Newly Diagnosed, Previously Untreated, Asymptomatic Stage II-IV Non-Bulky Follicular Non-Hodgkin's Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Active | 18 and over | CRUK-2004-001621-16
EU-20509, ROCHE-CRUK-001621-16, NCT00112931 |
Trial Description
Purpose:
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.
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.
Eligibility:
Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment/Intervention:
Patients will be randomly assigned (have an equal chance of being placed) to one of three groups.
Patients in group one will undergo observation only until disease progesses.
Patients in group two will receive an infusion of rituximab once a week for up to 4 weeks.
Patients in group three will receive rituximab as in group two. They will then receive an infusion of rituximab every 2 months for up to approximately 2 years.
Quality of life will be assessed periodically. Patients will be evaluated every 2 months for 2 years and every 3 months thereafter.
Important:
For more details about this trial, refer to the Health Professional version of the trial summary.
If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on
NCI's Web site.
Trial Contact Information
Trial Lead Organizations
University College of London Hospitals
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| Kirit Ardeshna, Protocol chair | | |
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Trial Sites
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| United Kingdom |
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| England |
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Birmingham |
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| | Birmingham Heartlands Hospital |
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| | D. W. Milligan, MD | |
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Email:
d.w.milligan@bham.ac.uk |
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Blackpool |
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| | Blackpool Victoria Hospital |
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| | Marian Macheta | |
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Email:
dr.macheta@bfuhospitals.nhs.uk |
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Bury St. Edmunds |
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| | West Suffolk Hospital |
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| | Wayne Thomas | |
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Email:
wayne.thomas@wsh.nhs.uk |
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Canterbury |
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| | Kent and Canterbury Hospital |
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| | Gillian Evans | | Ph: | 44-122-776-6877 ext. 8666061 | | |
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Carshalton |
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| | St. Helier Hospital |
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| | J Mercieca, MD | |
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Exeter |
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| | Royal Devon and Exeter Hospital |
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| | M. Joyner, MD | |
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Gateshead-Tyne and Wear |
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| | Queen Elizabeth Hospital |
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| | G. P. Summerfield, DM, FRCP, FRCPath | |
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Gillingham Kent |
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| | Medway Maritime Hospital |
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| | Maadh Aldouri, MD | |
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Email:
mdouri@doctors.org.uk |
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Hemel Hempstead |
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| | Hemel Hempstead General |
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| | J F M Harrison, MD | |
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Hull |
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| | Hull Royal Infirmary |
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| | Russell Patmore, MD | |
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Isleworth |
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| | West Middlesex University Hospital |
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| | M. Sekhar, MD | |
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Email:
mallika.sekhar@wmuh-tr.nthames.nhs.uk |
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Kettering, Northants |
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| | Kettering General Hosptial |
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| | M. Lyttelton, MD | |
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Email:
matthew.lyttelton@kgh.nhs.uk |
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Kidderminster
Worcestershire |
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| | Kidderminster Hospital |
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| | Robert Stockley | |
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King's Lynn |
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| | Queen Elizabeth Hospital |
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| | A. Keidan | |
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Leicester |
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| | Leicester Royal Infirmary |
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| | M. J. Dyer, MD | |
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Email:
mjsd1@le.ac.uk |
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London |
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| | St. George's Hospital |
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| | Ruth Pettengell, MD | |
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Maidstone |
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| | Maidstone Hospital |
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| | Don Gillett, FRCP, FRCPath | | Ph: | 44-189-282-3535 ext. 3278 | | |
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Email:
don.gillett@nhs.net |
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Newcastle-Upon-Tyne |
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| | Sir James Spence Institute of Child Health at Royal Victoria Infirmary |
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| | Anne Lennard | |
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Email:
a.l.lennard@ncl.ac.uk |
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Northwood |
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| | Mount Vernon Cancer Centre at Mount Vernon Hospital |
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| | Kirit Ardeshna | |
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Email:
kirit.ardeshna@uclh.nhs.uk |
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Preston |
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| | Rosemere Cancer Centre at Royal Preston Hospital |
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| | Ashoke Biswas | |
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Redditch, Worcestershire |
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| | Alexandra Healthcare NHS |
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| | Robert Stockley | |
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Romford |
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| | Oldchurch Hospital |
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| | Alison Brownell, MD | |
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Royal Tunbridge Wells, Kent |
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| | Pembury Hospital |
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| | Don Gillett, FRCP, FRCPath | | Ph: | 44-1892-823-535 ext. 3257 | | |
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Southampton |
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| | Southampton General Hospital |
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| | Peter Johnson, MD | |
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Email:
johnsonp@soton.ac.uk |
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Stafford |
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| | Staffordshire General Hospital |
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| | Paul Revell, MD | |
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Email:
jayne.anslow@msgh-tr.wmids.nhs.uk |
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Sutton |
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| | Royal Marsden - Surrey |
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| | David Cunningham, MD | |
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Email:
david.cunningham@rmh.nhs.uk |
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Torquay |
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| | Torbay Hospital |
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| | Deborah Turner | |
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Email:
deborah.turner2@nhs.net |
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Truro, Cornwall |
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| | Royal Cornwall Hospital |
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| | Anton Kruger | |
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Email:
anton.kruger@rcht.cornwall.nhs.uk |
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Weston-super-Mare |
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| | Weston General Hospital |
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| | Christopher Price, MD | | Ph: | 44-193-463-6363 ext. 3015 | | |
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Worcester |
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| | Worcester Royal Hospital |
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| | Robert Stockley | |
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| Scotland |
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Aberdeen |
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| | Aberdeen Royal Infirmary |
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| | Dominic Culligan, MD | |
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Email:
dominic.culligan@arh.grampian.scot.nhs.uk |
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Airdrie |
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| | Monklands General Hospital |
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| | Iain Singer | |
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East Kilbride |
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| | Hairmyres Hospital |
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| | Iain Singer | |
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Edinburgh |
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| | Edinburgh Cancer Centre at Western General Hospital |
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| | contact person | |
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Glasgow |
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| | Southern General Hospital |
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| | A E Morrison, MD | |
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Inverness |
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| | Raigmore Hospital |
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| | W. Murray | |
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Paisley |
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| | Royal Alexandra Hospital |
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| | Pamela Mckay, MD | |
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Wishaw |
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| | Wishaw General Hospital |
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| | Iain Singer | |
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| Wales |
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Cardiff |
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| | Velindre Cancer Center at Velindre Hospital |
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| | Timothy Maughan, MD | |
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Mid Glamorgan |
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| | Prince Charles Hospital |
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| | W. Bashi | |
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Rhyl, Denbighshire |
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| | Glan Clwyd Hospital |
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| | David Edwards | |
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Swansea |
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| | South West Wales Cancer Institute |
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| | Saad Al-Ismail, MD | |
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Email:
saad.al-ismail@swansea-tr.wales.nhs.uk |
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| Registry Information |
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| Official Title | | An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients with Advanced Stage, Asymptomatic, Non-Bulky Follicular Lymphoma |
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| Trial Start Date | | 2004-09-27 |
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| Trial Completion Date | | 2011-10-03 (estimated) |
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| Registered in ClinicalTrials.gov | | NCT00112931 |
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| Date Submitted to PDQ | | 2005-03-24 |
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| Information Last Verified | | 2007-06-26 |
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