Fludarabine versus Fludarabine plus Cyclophosphamide in first line therapy of younger patients (up to 65 years) with advanced Chronic Lymphocytic Leukemia

ISRCTN	ISRCTN75653261
DOI	https://doi.org/10.1186/ISRCTN75653261
ClinicalTrials.gov (NCT)	NCT00276848
Protocol serial number	CLL4
Sponsor	German CLL Study Group (GCLLSG)
Funders	CLL4 trial of the Geman CLL Study Group (GCLLSG), MedacSchering Onkologie

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Michael Hallek
Scientific

Kerpernerstr. 62
Cologne
50937
Germany

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia
Study acronym	F versus FC in CLL
Study objectives	If the combination therapy fludarabine plus cyclophosphamide, which has been shown very promising results in phase II studies, is superior to the chemotherapy with fludarabine alone, which is so far the standard first line treatment in Chronic Lymphocytic Leukemia (CLL) patients with physical good condition.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Chronic lymphocytic leukemia (CLL), advanced stage
Intervention	Fludarabine 25 mg/m^2/day intravenously for five days, repeated every 28 days, maximum of six courses. Fludarabine 30 mg/m^2/day for three days intravenously plus cyclophosphamide 250 mg/m^2/day for three days, both repeated every 28 days, maximum of six courses.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fludarabine, cyclophosphamide
Primary outcome measure(s)	Repsonse rates, quality of responses as well as progression free survival.
Key secondary outcome measure(s)	Survival, as well as toxicity and quality of life.
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	375
Key inclusion criteria	Patients with an age of up to 65 years with untreated CLL in advanced stage (all Binet stage C patients; Binet stage B with symptoms, which require therapy; Binet stage A with severe B-symptoms).
Key exclusion criteria	Patients with an age less than 18 and more than 65 years were excluded as well as patients with any previous treatment of CLL, life expectancy less than six months and an Eastern Cooperative Oncology Group performance status of more than two. Patients were also excluded if they had severe organ dysfunction, concomitant or previous other neoplasms or an autoimmune hemolytic anemia or thrombocytopenia.
Date of first enrolment	01/07/1999
Date of final enrolment	31/07/2003

Kerpernerstr. 62

Cologne
50937
Germany

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	01/02/2006	25/01/2019	Yes	No
Results article	results	01/05/2007	25/01/2019	Yes	No

25/01/2019: Publication reference added