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

Not Applicable

Completed

• Conditions: Waldenstrom's macroglobulinaemia and related disorders; Cancer; Malignant immunoproliferative diseases

• Registration Number: ISRCTN56052618
• Lead Sponsor: Taunton and Somerset NHS Foundation Trust (UK)

Brief Summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15794869 2. 2013 results in https://www.ncbi.nlm.nih.gov/pubmed/23233721

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-03-24
• Study Completion: 2009-06-30
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added as of 20/05/2008: <br>1. Response to therapy (complete and partial response rates)<br>2. Duration of response

Secondary Outcome Measures

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