Condition category
Cancer
Date applied
24/08/2004
Date assigned
21/09/2004
Last edited
02/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Peter Hillmen

ORCID ID

Contact details

Department of Haematology
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Additional identifiers

EudraCT number

2004-003982-34

ClinicalTrials.gov number

NCT00337246

Protocol/serial number

N/A

Study information

Scientific title

Acronym

UKCLL 01 FCM/FCM-R

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomized, controlled, open-label, parallel group, multicenter study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Lymphocytic Leukaemia (CLL)

Intervention

All patients will receive fludarabine with cyclophosphamide plus mitoxantrone (FCM) and half will be randomised to receive simultaneous rituximab (FCM-R)

Intervention type

Drug

Phase

Phase II

Drug names

cyclophosphamide, fludarabine phosphate, mitoxantrone, rituximab

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/07/2005

Overall trial end date

31/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

56

Participant 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.

Recruitment start date

01/07/2005

Recruitment end date

31/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Haematology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds Acute NHS Trust (UK)

Sponsor details

Research and Development Directorate
6th Floor
Wellcome Wing
The General Infirmary at Leeds
Great George Street
Leeds
LS1 3EX
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

ML175555 Roche pharmaceutical have provided an educational grant covering the costs of the trial

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

Publication citations

  1. Results

    Hillmen P, Cohen DR, Cocks K, Pettitt A, Sayala HA, Rawstron AC, Kennedy DB, Fegan C, Milligan DW, Radford J, Mercieca J, Dearden C, Ezekwisili R, Smith AF, Brown J, Booth GA, Varghese AM, Pocock C, , A randomized phase II trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab in previously treated chronic lymphocytic leukaemia., Br. J. Haematol., 2011, 152, 5, 570-578, doi: 10.1111/j.1365-2141.2010.08317.x.

Additional files

Editorial Notes