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 number	NCT00276848
Secondary identifying numbers	CLL4

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Prof Michael Hallek
Scientific

Kerpernerstr. 62
Cologne
50937
Germany

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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 hypothesis	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.
Condition	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fludarabine, cyclophosphamide
Primary outcome measure	Repsonse rates, quality of responses as well as progression free survival.
Secondary outcome measures	Survival, as well as toxicity and quality of life.
Overall study start date	01/07/1999
Overall study end date	31/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	375
Participant 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).
Participant 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.
Recruitment start date	01/07/1999
Recruitment end date	31/07/2003

Kerpernerstr. 62

Cologne
50937
Germany

German CLL Study Group (GCLLSG)
Not defined

Department of Internal Medicine I
University of Cologne
Cologne
50924
Germany

Email	cllstudie@uk-koeln.de

Research organisation

CLL4 trial of the Geman CLL Study Group (GCLLSG)

No information available

MedacSchering Onkologie

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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