A randomised Phase II Trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab (R) in previously treated chronic lymphocytic leukaemia

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukaemia (CLL); Cancer; Leukaemia

• Registration Number: ISRCTN77546448
• Lead Sponsor: eeds Acute NHS Trust (UK)

Brief Summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21231927

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-21
• Study Completion: 2008-07-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

CLL requiring therapy, had previous treatment with at least one chemotherapeutic regimen, be capable of giving written informed consent, World Health Organisation (WHO) 0, 1 or 2, life expectancy of at least 12 weeks.

Exclusion Criteria

Previous treatment with F (or other purine analogues) combined with C and M, previous treatment with R, past history of anaphylaxis following exposure to rat or mouse derived complementarity determining region grafted humanized monoclonal antibodies, toxicity attributable to purine analogues, active infection, other severe, concurrent diseases or mental disorders that could interfere with their ability to participate in the study, patients with a creatinine clearance of less than 30 ml/min (measured or derived by the Cockcroft formula), pregnant or unwilling to use adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration.