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AzTrials

LymphomaPhase 3NCT00608374

Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma

A Phase 3 study testing chlorambucil, fludarabine phosphate and quality-of-life assessment in people with Lymphoma, run by Taunton and Somerset Hospital at 49 sites in 2 countries.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
chlorambucil, fludarabine phosphate and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
400 participants
Where
49 sitesin 2 countries
Study dates
Jun 2006to Jan 2013
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of Waldenström macroglobulinemia, splenic lymphoma with villous lymphocytes (SLVL), or non-IgM lymphoplasmacytic lymphoma based on morphological and immunophenotypic criteria
  • Bone marrow should be assessed by two-color flow cytometry for the expression of the following antigens:
  • Surface Ig
  • CD19
  • CD20
  • CD5
  • CD10
  • CD23
  • Previously untreated disease requiring therapeutic intervention (as judged by the primary physician), as indicated by ≥ 1 of the following:
  • Hemoglobin < 10 g/dL
  • ANC < 1.5 x 10^9/L
  • Platelet count < 150 x 10^9/L
  • Clinical evidence of hyperviscosity in terms of neurological or ocular disturbance
  • Patients with disease detected by clonal cells alone are not eligible

PATIENT CHARACTERISTICS:

  • Performance status 0-2
  • Life expectancy > 6 months
  • Serum creatinine < 200 mmol/L
  • AST and ALT < 2 times upper limit of normal
  • Negative direct Coomb's test
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
  • No severe or life-threatening cardiac, pulmonary, neurological, psychiatric, or metabolic disease
  • No other concurrent malignancy
  • No AIDS or AIDS-related complex
  • No evidence of active hepatitis C infection

PRIOR CONCURRENT THERAPY:

  • Prior plasmapheresis for control of clinically significant hyperviscosity allowed
  • Prior splenectomy for SLVL allowed

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United Kingdom44 sites

  • Monklands General Hospital

    Airdrie, Scotland, ML6 0JF

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Royal United Hospital

    Bath, England, BA1 3NG

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Royal Bournemouth Hospital

    Bournemouth, England, BH7 7DW

  • Bradford Royal Infirmary

    Bradford, England, BD9 6RJ

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Gloucestershire Oncology Centre at Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Saint Richards Hospital

    Chichester, England, P019 4SE

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Southern General Hospital

    Glasgow, Scotland, G51 4TF

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Harrogate District Hospital

    Harrogate, England, HG2 7SX

  • Hereford Hospitals

    Hereford, England, HR1 2ER

  • Watford General Hospital

    Herts, England, WD18 0HB

  • Wycombe General Hospital

    High Wycombe, England

  • Hull Royal Infirmary

    Hull, England, HU3 2KZ

  • Queen Elizabeth Hospital

    Kings Lynn, England, PE30 4ET

  • Leeds General Infirmary

    Leeds, England, LS1 3EX

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • University College Hospital - London

    London, England, WC1E 6AU

  • Royal Manchester Children's Hospital

    Manchester, England, M27 4HA

  • Trafford General Hospital

    Manchester, England, M31 3SL

  • Oxford Radcliffe Hospital

    Oxford, England, 0X3 9DU

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

  • Berkshire Cancer Centre at Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • Rotherham General Hospital

    Rotherham, England, S60 2UD

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • Taunton and Somerset Hospital

    Taunton Somerset, England, TA1 5DA

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, Cornwall, England, TR1 3LJ

  • Kent and Sussex Hospital

    Tunbridge Wells, Kent, England, TN4 8AT

  • Pinderfields General Hospital

    Wakefield, Scotland, WF1 4DG

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Australia5 sites

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

About this study

Official title: A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes

RATIONALE: Drugs used in chemotherapy, such as chlorambucil and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether chlorambucil is more effective than fludarabine in treating Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.

PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works compared with fludarabine as first-line therapy in treating patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma, or lymphoplasmacytic lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of first-line therapy comprising chlorambucil vs fludarabine phosphate in patients with previously untreated Waldenström macroglobulinemia, splenic lymphoma with villous lymphocytes, or non-IgM lymphoplasmacytic lymphoma.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Waldenström macroglobulinemia vs splenic lymphoma with villous lymphocytes vs non-IgM lymphoplasmacytic lymphoma). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral chlorambucil on days 1-10. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive fludarabine phosphate orally or IV on days 1-5. Treatment repeats every 28 days for 3-6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo quality of life assessment at baseline.

Conditions
Lymphoma
Being tested
chlorambucil, fludarabine phosphate, quality-of-life assessment
Keywords
Waldenström macroglobulinemia, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma
Medical subject headings
Lymphoma, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone

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. Response to therapy (complete and partial response rates)

  2. Duration of response

Secondary outcomes (4)

  1. Improvement in hematological parameters

  2. Toxicity

  3. Quality of life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life-30 questionnaire

  4. Survival

Timeline

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

  1. First posted6 Feb 2008 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2009
  4. Study completionJan 2013

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
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00608374
Sponsor's protocol ID
CDR0000581143
Other IDs
TSH-WM1, ISRCTN56052618
Status last verified
Jun 2009
First submitted
21 Dec 2007
Last updated
26 Aug 2013
Results posted
No

Publications

  • Leblond V, Johnson S, Chevret S, Copplestone A, Rule S, Tournilhac O, Seymour JF, Patmore RD, Wright D, Morel P, Dilhuydy MS, Willoughby S, Dartigeas C, Malphettes M, Royer B, Ewings M, Pratt G, Lejeune J, Nguyen-Khac F, Choquet S, Owen RG. Results of a randomized trial of chlorambucil versus fludarabine for patients with untreated Waldenstrom macroglobulinemia, marginal zone lymphoma, or lymphoplasmacytic lymphoma. J Clin Oncol. 2013 Jan 20;31(3):301-7. doi: 10.1200/JCO.2012.44.7920. Epub 2012 Dec 10.

    PubMed 23233721

  • Nguyen-Khac F, Lambert J, Chapiro E, Grelier A, Mould S, Barin C, Daudignon A, Gachard N, Struski S, Henry C, Penther D, Mossafa H, Andrieux J, Eclache V, Bilhou-Nabera C, Luquet I, Terre C, Baranger L, Mugneret F, Chiesa J, Mozziconacci MJ, Callet-Bauchu E, Veronese L, Blons H, Owen R, Lejeune J, Chevret S, Merle-Beral H, Leblondon V; Groupe Francais d'Etude de la Leucemie Lymphoide Chronique et Maladie de Waldenstrom (GFCLL/MW); Groupe Ouest-Est d'etude des Leucemie Aigues et Autres Maladies du Sang (GOELAMS); Groupe d'Etude des Lymphomes de l'Adulte (GELA). Chromosomal aberrations and their prognostic value in a series of 174 untreated patients with Waldenstrom's macroglobulinemia. Haematologica. 2013 Apr;98(4):649-54. doi: 10.3324/haematol.2012.070458. Epub 2012 Oct 12.

    PubMed 23065509

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing chlorambucil, fludarabine phosphate and quality-of-life assessment in people with Lymphoma, run by Taunton and Somerset Hospital at 49 sites in 2 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 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United Kingdom, Australia. 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?

Response to therapy (complete and partial response rates). The study lists 2 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 NCT00608374, 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 26 Aug 2013.

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