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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112931
First received: June 2, 2005
Last updated: August 23, 2013
Last verified: June 2007
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time until initiation of therapy (chemotherapy or radiotherapy) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of clinical spontaneous remission [ Designated as safety issue: No ]
  • Cause specific survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2004
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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 and older
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 Recruiting
Birmingham, England, United Kingdom, B9 5SS
Contact: D. W. Milligan, MD    44-121-424-3699    d.w.milligan@bham.ac.uk   
Blackpool Victoria Hospital Recruiting
Blackpool, England, United Kingdom, FY3 8NR
Contact: Marian Macheta    44-125-330-3760    dr.macheta@bfuhospitals.nhs.uk   
West Suffolk Hospital Recruiting
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Contact: Wayne Thomas    44-128-471-2754    wayne.thomas@wsh.nhs.uk   
Kent and Canterbury Hospital Recruiting
Canterbury, England, United Kingdom, CT1 3NG
Contact: Gillian Evans    44-122-776-6877 ext. 8666061      
St. Helier Hospital Recruiting
Carshalton, England, United Kingdom, SM5 1AA
Contact: J Mercieca, MD    44-208-296-2972      
Royal Devon and Exeter Hospital Recruiting
Exeter, England, United Kingdom, EX2 5DW
Contact: M. V. Joyner, MD    44-139-240-2928      
Queen Elizabeth Hospital Recruiting
Gateshead-Tyne and Wear, England, United Kingdom, NE9 6SX
Contact: G. P. Summerfield, DM, FRCP, FRCPath    44-191-445-2878      
Medway Maritime Hospital Recruiting
Gillingham Kent, England, United Kingdom, ME7 5NY
Contact: Maadh Aldouri, MD    44-1634-82-5214    mdouri@doctors.org.uk   
Hemel Hempstead General Recruiting
Hemel Hempstead, England, United Kingdom, HP2 4AD
Contact: J F M Harrison, MD    44-144-221-3141      
Hull Royal Infirmary Recruiting
Hull, England, United Kingdom, HU3 2KZ
Contact: Russell Patmore, MD    44-148-232-8541      
West Middlesex University Hospital Recruiting
Isleworth, England, United Kingdom, TW7 6AF
Contact: M. Sekhar, MD    44-208-321-5716    mallika.sekhar@wmuh-tr.nthames.nhs.uk   
Kettering General Hosptial Recruiting
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Contact: M. Lyttelton, MD    44-536-492-699    matthew.lyttelton@kgh.nhs.uk   
Kidderminster Hospital Recruiting
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
Contact: Robert Stockley    44-160-576-0635      
Queen Elizabeth Hospital Recruiting
King's Lynn, England, United Kingdom, PE30 4ET
Contact: A. J. Keidan    44-155-613-613      
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: M. J. Dyer, MD    44-116-252-5589    mjsd1@le.ac.uk   
St. George's Hospital Recruiting
London, England, United Kingdom, SW17 0QT
Contact: Ruth Pettengell, MD    44-208-672-1255      
Maidstone Hospital Recruiting
Maidstone, England, United Kingdom, ME16 9QQ
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 Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP
Contact: Anne Lennard    44-191-282-5457    a.l.lennard@ncl.ac.uk   
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Kirit Ardeshna    44-192-384-4413    kirit.ardeshna@uclh.nhs.uk   
Rosemere Cancer Centre at Royal Preston Hospital Recruiting
Preston, England, United Kingdom, PR2 9HT
Contact: Ashoke Biswas    44-177-252-3097      
Alexandra Healthcare NHS Recruiting
Redditch, Worcestershire, England, United Kingdom, B98 7UB
Contact: Robert Stockley    44-190-576-0635      
Oldchurch Hospital Recruiting
Romford, England, United Kingdom, RM7 OBE
Contact: Alison Brownell, MD    44-170-345-533      
Pembury Hospital Recruiting
Royal Tunbridge Wells, Kent, England, United Kingdom, TN2 4QJ
Contact: Don S. Gillett, FRCP, FRCPath    44-1892-823-535 ext. 3257      
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Peter Johnson, MD    44-238-079-6185    johnsonp@soton.ac.uk   
Staffordshire General Hospital Recruiting
Stafford, England, United Kingdom, ST16 3SA
Contact: Paul Revell, MD    44-178-525-7731    jayne.anslow@msgh-tr.wmids.nhs.uk   
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: David Cunningham, MD    44-20-8661-3279    david.cunningham@rmh.nhs.uk   
Torbay Hospital Recruiting
Torquay, England, United Kingdom, TQ2 7AA
Contact: Deborah Turner    44-180-365-5244    deborah.turner2@nhs.net   
Royal Cornwall Hospital Recruiting
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Contact: Anton Kruger    44-187-225-2506    anton.kruger@rcht.cornwall.nhs.uk   
Weston General Hospital Recruiting
Weston-super-Mare, England, United Kingdom, BS23 4TQ
Contact: Christopher Price, MD    44-193-463-6363 ext. 3015      
Worcester Royal Hospital Recruiting
Worcester, England, United Kingdom, WR5 1DD
Contact: Robert Stockley    44-190-576-0635      
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Dominic J. Culligan, MD    44-122-455-3394    dominic.culligan@arh.grampian.scot.nhs.uk   
Monklands General Hospital Recruiting
Airdrie, Scotland, United Kingdom, ML6 0JF
Contact: Iain Singer    44-123-271-2104      
Hairmyres Hospital Recruiting
East Kilbride, Scotland, United Kingdom, G75 8RG
Contact: Iain Singer    44-123-671-2104      
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: contact person    44-131-537-1903      
Southern General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: A E Morrison, MD    44-141-201-1100      
Raigmore Hospital Recruiting
Inverness, Scotland, United Kingdom, 1V2 3UJ
Contact: W. Murray    44-146-370-4259      
Royal Alexandra Hospital Recruiting
Paisley, Scotland, United Kingdom
Contact: Pamela Mckay, MD    44-141-580-4225      
Wishaw General Hospital Recruiting
Wishaw, Scotland, United Kingdom, ML2 0DP
Contact: Iain Singer    44-123-371-2104      
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF14 2TL
Contact: Timothy Maughan, MD    44-2920-316-904      
Prince Charles Hospital Recruiting
Mid Glamorgan, Wales, United Kingdom, CF47 9DT
Contact: W. M. Bashi    44-168-572-8518      
Glan Clwyd Hospital Recruiting
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Contact: David R. Edwards    44-174-558-3910      
South West Wales Cancer Institute Recruiting
Swansea, Wales, United Kingdom, SA2 8QA
Contact: Saad Al-Ismail, MD    44-1792-285-024    saad.al-ismail@swansea-tr.wales.nhs.uk   
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Kirit Ardeshna Mount Vernon Cancer Centre at Mount Vernon Hospital
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014