Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: 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
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Intervention
Name: rituximab
Type: Biological
Overall Status
Recruiting
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. 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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Status: Recruiting
Contact: D. W. Milligan, MD - 44-121-424-3699 - d.w.milligan@bham.ac.uk
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Status: Recruiting
Contact: Marian Macheta - 44-125-330-3760 - dr.macheta@bfuhospitals.nhs.uk
West Suffolk Hospital
Bury St. Edmunds, England, United Kingdom
Status: Recruiting
Contact: Wayne Thomas - 44-128-471-2754 - wayne.thomas@wsh.nhs.uk
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Status: Recruiting
Contact: Gillian Evans - 44-122-776-6877 ext. 8666061
St. Helier Hospital
Carshalton, England, United Kingdom
Status: Recruiting
Contact: J Mercieca, MD - 44-208-296-2972
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Status: Recruiting
Contact: M. V. Joyner, MD - 44-139-240-2928
Queen Elizabeth Hospital
Gateshead-Tyne and Wear, England, United Kingdom
Status: Recruiting
Contact: G. P. Summerfield, DM, FRCP, FRCPath - 44-191-445-2878
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom
Status: Recruiting
Contact: Maadh Aldouri, MD - 44-1634-82-5214 - mdouri@doctors.org.uk
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom
Status: Recruiting
Contact: J F M Harrison, MD - 44-144-221-3141
Hull Royal Infirmary
Hull, England, United Kingdom
Status: Recruiting
Contact: Russell Patmore, MD - 44-148-232-8541
West Middlesex University Hospital
Isleworth, England, United Kingdom
Status: Recruiting
Contact: M. Sekhar, MD - 44-208-321-5716 - mallika.sekhar@wmuh-tr.nthames.nhs.uk
Kettering General Hosptial
Kettering, Northants, England, United Kingdom
Status: Recruiting
Contact: M. Lyttelton, MD - 44-536-492-699 - matthew.lyttelton@kgh.nhs.uk
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom
Status: Recruiting
Contact: Robert Stockley - 44-160-576-0635
Queen Elizabeth Hospital
King's Lynn, England, United Kingdom
Status: Recruiting
Contact: A. J. Keidan - 44-155-613-613
Leicester Royal Infirmary
Leicester, England, United Kingdom
Status: Recruiting
Contact: M. J. Dyer, MD - 44-116-252-5589 - mjsd1@le.ac.uk
St. George's Hospital
London, England, United Kingdom
Status: Recruiting
Contact: Ruth Pettengell, MD - 44-208-672-1255
Maidstone Hospital
Maidstone, England, United Kingdom
Status: Recruiting
Contact: Don S. Gillett, FRCP, FRCPath - 44-189-282-3535 ext. 3278 - don.gillett@nhs.net
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle-Upon-Tyne, England, United Kingdom
Status: Recruiting
Contact: Anne Lennard - 44-191-282-5457 - a.l.lennard@ncl.ac.uk
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Status: Recruiting
Contact: Kirit Ardeshna - 44-192-384-4413 - kirit.ardeshna@uclh.nhs.uk
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Status: Recruiting
Contact: Ashoke Biswas - 44-177-252-3097
Alexandra Healthcare NHS
Redditch, Worcestershire, England, United Kingdom
Status: Recruiting
Contact: Robert Stockley - 44-190-576-0635
Oldchurch Hospital
Romford, England, United Kingdom
Status: Recruiting
Contact: Alison Brownell, MD - 44-170-345-533
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom
Status: Recruiting
Contact: Don S. Gillett, FRCP, FRCPath - 44-1892-823-535 ext. 3257
Southampton General Hospital
Southampton, England, United Kingdom
Status: Recruiting
Contact: Peter Johnson, MD - 44-238-079-6185 - johnsonp@soton.ac.uk
Staffordshire General Hospital
Stafford, England, United Kingdom
Status: Recruiting
Contact: Paul Revell, MD - 44-178-525-7731 - jayne.anslow@msgh-tr.wmids.nhs.uk
Royal Marsden - Surrey
Sutton, England, United Kingdom
Status: Recruiting
Contact: David Cunningham, MD - 44-20-8661-3279 - david.cunningham@rmh.nhs.uk
Torbay Hospital
Torquay, England, United Kingdom
Status: Recruiting
Contact: Deborah Turner - 44-180-365-5244 - deborah.turner2@nhs.net
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
Status: Recruiting
Contact: Anton Kruger - 44-187-225-2506 - anton.kruger@rcht.cornwall.nhs.uk
Weston General Hospital
Weston-super-Mare, England, United Kingdom
Status: Recruiting
Contact: Christopher Price, MD - 44-193-463-6363 ext. 3015
Worcester Royal Hospital
Worcester, England, United Kingdom
Status: Recruiting
Contact: Robert Stockley - 44-190-576-0635
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Status: Recruiting
Contact: Dominic J. Culligan, MD - 44-122-455-3394 - dominic.culligan@arh.grampian.scot.nhs.uk
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Status: Recruiting
Contact: Iain Singer - 44-123-271-2104
Hairmyres Hospital
East Kilbride, Scotland, United Kingdom
Status: Recruiting
Contact: Iain Singer - 44-123-671-2104
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Status: Recruiting
Contact: contact person - 44-131-537-1903
Southern General Hospital
Glasgow, Scotland, United Kingdom
Status: Recruiting
Contact: A E Morrison, MD - 44-141-201-1100
Raigmore Hospital
Inverness, Scotland, United Kingdom
Status: Recruiting
Contact: W. Murray - 44-146-370-4259
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Status: Recruiting
Contact: Pamela Mckay, MD - 44-141-580-4225
Wishaw General Hospital
Wishaw, Scotland, United Kingdom
Status: Recruiting
Contact: Iain Singer - 44-123-371-2104
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Status: Recruiting
Contact: Timothy Maughan, MD - 44-2920-316-904
Prince Charles Hospital
Mid Glamorgan, Wales, United Kingdom
Status: Recruiting
Contact: W. M. Bashi - 44-168-572-8518
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom
Status: Recruiting
Contact: David R. Edwards - 44-174-558-3910
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Status: Recruiting
Contact: Saad Al-Ismail, MD - 44-1792-285-024 - saad.al-ismail@swansea-tr.wales.nhs.uk
Start Date
September 2004
Sponsors
University College London Hospitals
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page