A randomised comparison of chlorambucil, fludarabine and fludarabine plus cyclophosphamide

Not Applicable

Completed

• Conditions: Chronic lymphocytic leukaemia (CLL); Cancer; Leukaemia

• Registration Number: ISRCTN58585610
• Lead Sponsor: Institute of Cancer Research (UK)

Brief Summary

1. 2007 results of assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia in http://www.ncbi.nlm.nih.gov/pubmed/17658394 2. 2008 results on the prognostic significance of a positive direct antiglobulin test in chronic lymphocytic leukemia in http://www.ncbi.nlm.nih.gov/pubmed/18055869 3. 2008 results on the scan of nonsynonymous SNPs in CLL4 trial patients for the identification of genetic variants influencing prognosis in http://www.ncbi.nlm.nih.gov/pubmed/18006695 4. 2008 results on baseline health-related quality of life in http://www.ncbi.nlm.nih.gov/pubmed/19016733 5. 2010 results of identification of prognostic makers in http://www.ncbi.nlm.nih.gov/pubmed/20511662 6. 2010 results of relative importance of prognostic makers in http://www.ncbi.nlm.nih.gov/pubmed/20511662

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-07-01
• Study Completion: 2004-10-30
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Patients are diagnosed with B-cell chronic lymphocytic leukaemia
2. They have not previously been treated
3. They have been diagnosed by a persistent lymphocytosis and bone marrow infiltration of at least 40% and require treatment
4. They are classified as having stage A progressive, stage B or stage C disease using the International Binet Staging System
5. They have given informed consent

Exclusion Criteria

1. Patients with other life-threatening diseases
2. Patients unable or unwilling to give informed consent
3. Renal failure (creatinine clearance less than 30 ml/min)
4. Hepatic enzymes and bilirubin greater than twice the upper limit of normal, unless due to CLL
5. Pregnant women or women at risk of pregnancy
6. Patients who for other reasons are not expected to complete the study
7. Patients with a diagnosis other than CLL after central review of markers and morphology

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival

Secondary Outcome Measures

Name	Time	Method
1. Response to therapy<br>2. Duration of response<br>3. Toxicity<br>4. Quality of life