A randomised trial of chlorambucil versus fludarabine as initial therapy of Waldenstrom's macroglobulinaemia and splenic lymphoma with villous lymphocytes

ISRCTN	ISRCTN56052618
DOI	https://doi.org/10.1186/ISRCTN56052618
ClinicalTrials.gov number	NCT00608374
Secondary identifying numbers	N/A

Submission date: 06/02/2004
Registration date: 24/03/2004
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Stephen Johnson
Scientific

Haematology Department
Taunton and Somerset NHS Trust
Musgrove Park
Taunton
Somerset
Taunton
TA1 5DA
United Kingdom

Phone	+44 (0)1823 342269
Email	no@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A randomised trial of chlorambucil versus fludarabine as initial therapy of Waldenstrom's macroglobulinaemia and splenic lymphoma with villous lymphocytes
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2006
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Added as of 20/05/2008: 400
Key inclusion criteria	All patients with previously untreated disease who require therapy as judged by their primary physician and who satisfy the eligibilty criteria.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2006
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Australia
England
United Kingdom

Study participating centre

Haematology Department

Taunton
TA1 5DA
United Kingdom

Sponsor information

Taunton and Somerset NHS Foundation Trust (UK)
Hospital/treatment centre

Musgrove Park
Somerset
Taunton
TA1 5DA
England
United Kingdom

Phone	+44 (0)1823 333444
Email	paul.ewings@tst.nhs.uk
"ROR"	https://ror.org/02y5f7327

Funders

Funder type

Industry

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Plain English results			No	Yes
Protocol article	protocol	01/03/2005	Yes	No
Results article	results	20/01/2013	Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
29/08/2018: Publication reference added.