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

ISRCTN	ISRCTN77546448
DOI	https://doi.org/10.1186/ISRCTN77546448
ClinicalTrials.gov (NCT)	NCT00337246
Clinical Trials Information System (CTIS)	2004-003982-34
Protocol serial number	N/A
Sponsor	Leeds Acute NHS Trust (UK)
Funder	ML175555 Roche pharmaceutical have provided an educational grant covering the costs of the trial

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Peter Hillmen
Scientific

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

Primary study design	Interventional
Study design	Randomized, controlled, open-label, parallel group, multicenter study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised Phase II Trial of fludarabine, cyclophosphamide and mitoxantrone (FCM) with or without rituximab (R) in previously treated chronic lymphocytic leukaemia
Study acronym	UKCLL 01 FCM/FCM-R
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	cyclophosphamide, fludarabine phosphate, mitoxantrone, rituximab
Primary outcome measure(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/07/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	56
Key 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.
Key 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.
Date of first enrolment	01/07/2005
Date of final enrolment	31/07/2008

Department of Haematology

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)