Condition category
Cancer
Date applied
06/02/2004
Date assigned
24/03/2004
Last edited
19/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.waldenstroms.org/

Contact information

Type

Scientific

Primary contact

Dr Stephen Johnson

ORCID ID

Contact details

Haematology Department
Taunton and Somerset NHS Trust
Musgrove Park
Taunton
Somerset
Taunton
TA1 5DA
United Kingdom
+44 (0)1823 342269

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00608374

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Added as of 20/05/2008:
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 randomised 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.

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

Please note that, as of 20/05/2008, Australia was added to the list of countries of recruitment (previously United Kingdom only).

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Waldenstrom's macroglobulinaemia and related disorders

Intervention

Current interventions as of 20/05/2008:
This is a multicentre study. Patients are stratified according to disease (Waldenström macroglobulinemia versus splenic lymphoma with villous lymphocytes vs non-IgM lymphoplasmacytic lymphoma). Patients are randomised 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.

Previous interventions:
Chlorambucil versus fludarabine

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added as of 20/05/2008:
1. Response to therapy (complete and partial response rates)
2. Duration of response

Secondary outcome measures

Added as of 20/05/2008:
1. Improvement in haematological parameters
2. Toxicity
3. Quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life-30 questionnaire
4. Survival

Overall trial start date

01/06/2006

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with previously untreated disease who require therapy as judged by their primary physician and who satisfy the eligibilty criteria.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added as of 20/05/2008: 400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2006

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

Haematology Department
Taunton
TA1 5DA
United Kingdom

Sponsor information

Organisation

Taunton and Somerset NHS Foundation Trust (UK)

Sponsor details

Musgrove Park
Somerset
Taunton
TA1 5DA
United Kingdom
+44 (0)1823 333444
paul.ewings@tst.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Schering Healthcare Ltd (UK) - provided educational grant towards the website construction/administration costs and data management

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15794869

Publication citations

  1. Protocol

    Johnson SA, Owen RG, Oscier DG, Leblond V, Levy V, Jaeger U, Seymour JF, Phase III study of chlorambucil versus fludarabine as initial therapy for Waldenstrom's macroglobulinemia and related disorders., Clin Lymphoma, 2005, 5, 4, 294-297.

Additional files

Editorial Notes