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LymphomaPhase 3NCT00006250

Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Non-Hodgkin's Lymphoma

A Phase 3 study testing chlorambucil, dexamethasone and fludarabine phosphate in people with Lymphoma, run by Lymphoma Trials Office at 59 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
chlorambucil, dexamethasone and fludarabine phosphate
How many people
500 participants
Where
59 sitesUnited Kingdom
Study dates
May 2000to not given
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma
  • REAL classification grade I, II, or III
  • Treatment necessity indicated by presence of the following:
  • B symptoms
  • Bone marrow failure
  • Bulky or progressive disease
  • Compression syndromes
  • No CNS involvement

PATIENT CHARACTERISTICS:

Age:

  • 18 to 70

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • No autoimmune hemolytic anemia or active hemolysis
  • Direct Coombs' negative

Hepatic:

  • Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)*
  • Bilirubin no greater than 2.5 times ULN* NOTE: *Unless attributable to lymphoma

Renal:

  • Creatinine no greater than 2.5 times ULN (unless attributable to lymphoma)

Cardiovascular:

  • No severe cardiac failure
  • Ejection fraction at least 45%

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for at least 6 months after study
  • HIV negative
  • No prior malignancy except carcinoma in situ of the cervix or squamous cell skin cancer
  • No other serious medical disease that would limit lifespan or ability to tolerate chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent systemic corticosteroids

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior therapy

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United Kingdom59 sites

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Basildon University Hospital

    Basildon, England, SS16 5NL

  • Centre for Cancer Research and Cell Biology at Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Bradford Hospitals NHS Trust

    Bradford, England, BD9 6RJ

  • Kent and Canterbury Hospital

    Canterbury, England, CT2 7NR

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XN

  • St Helier Hospital

    Carshalton, England, SM5 1AA

  • Saint Richards Hospital

    Chichester, England, P019 4SE

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Craigavon Area Hospital

    Craigavon, Northern Ireland, BT63 5QQ

  • Dartford & Gravesham NHS Trust, Joyce Green Hospital

    Dartford Kent, England, DA1 5PL

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Ulster Hospital

    Dundonald, Northern Ireland, BT16

  • Epsom General Hospital

    Epsom Surrey, England, KT18 7E9

  • Northwick Park Hospital

    Harrow, England, HA1 3UJ

  • Wycombe General Hospital

    High Wycombe, England

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Ipswich Hospital NHS Trust

    Ipswich, England, IP4 5PD

  • West Middlesex University Hospital

    Isleworth, England, TW7 6AF

  • Kettering General Hosptial

    Kettering, Northants, England, NNI6 8UZ

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Clinical Trials and Research Unit of the University of Leeds

    Leeds, England, LS2 9N9

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Aintree University Hospital

    Liverpool, England, L9 7AL

  • St. Thomas' Hospital

    London, England, SE1 7EH

  • St. Georges, University of London

    London, England, SW17 ORE

  • Great Ormond Street Hospital for Children NHS Trust

    London, England, WC1N 3JH

  • University College of London Hospitals

    London, England, WIT 3AA

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

  • Glan Clywd District General Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Rotherham District General Hospital - NHS Trust

    Rotherham, England, S60 2UD

  • Pembury Hospital

    Royal Tunbridge Wells, Kent, England, TN2 4QJ

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Royal Hallamshire Hospital

    Sheffield, England, S1O 2JF

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Singleton Hospital of the Swansea NHS Trust

    Swansea, Wales, SA2 8QA

  • Taunton and Somerset Hospital

    Taunton Somerset, England, TA1 5DA

  • Torbay Hospital

    Torquay Devon, England, TQ2 7AA

  • Hillingdon Hospital

    Uxbridge, England, UB8 3NN

  • Pinderfields Hospital NHS Trust

    Wakefield, Scotland, WF1 4DG

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Good Hope Hospital Trust

    West Midlands, England, B75 7RR

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

  • Worthing Hospital

    Worthing, England, BN11 2DH

  • Yeovil District Hospital

    Yeovil - Somerset, England, BA21 4AT

  • Cancer Care Centre at York Hospital

    York, England, Y031 8HE

Other trials in United Kingdom

About this study

Official title: Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival rate, progression free survival rate, clinical and molecular remission rates, and time to treatment failure in patients with newly diagnosed stage III or IV follicular non-Hodgkin's lymphoma treated with chlorambucil, mitoxantrone, and dexamethasone versus fludarabine, mitoxantrone, and dexamethasone.
  • Compare the efficacy and tolerability of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to International Prognostic Index score [low risk (score 1) vs intermediate low risk (score 2) vs intermediate high risk (score 3) vs high risk (score 4 or 5)]. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive mitoxantrone IV on day 1, oral chlorambucil on days 1-10, and oral dexamethasone on days 1-5.
  • Arm II: Patients receive mitoxantrone and dexamethasone as in arm I and fludarabine IV on days 1-3.

Treatment continues every 4 weeks for 4-8 courses.

Patients are followed at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter until clinical relapse.

PROJECTED ACCRUAL: A total of 500 patients (250 per arm) will be accrued for this study within 4 years.

Conditions
Lymphoma
Being tested
chlorambucil, dexamethasone, fludarabine phosphate, mitoxantrone hydrochloride
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
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.

What is being measured

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

  1. Time to treatment failure

  2. Progression-free survival rate

  3. Overall survival rate

Secondary outcomes (2)

  1. Clinical remission rate

  2. Molecular remission rate

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2000

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
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006250
Sponsor's protocol ID
CDR0000068182
Other IDs
BNLI-MCD/FMD, EU-20035
Status last verified
Mar 2007
First submitted
11 Sep 2000
Last updated
20 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chlorambucil, dexamethasone and fludarabine phosphate in people with Lymphoma, run by Lymphoma Trials Office at 59 sites in United Kingdom.

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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United Kingdom. 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?

Results are not available in the source record.

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 to treatment failure. The study lists 3 primary outcomes in all. 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 NCT00006250.

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 20 Sep 2013.

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