Condition category
Cancer
Date applied
02/03/2005
Date assigned
26/04/2005
Last edited
05/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Hallek

ORCID ID

Contact details

Kerpernerstr. 62
Cologne
50937
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00276848

Protocol/serial number

CLL4

Study information

Scientific title

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Phase

Not Specified

Drug names

Fludarabine, cyclophosphamide

Primary outcome measures

Repsonse rates, quality of responses as well as progression free survival.

Secondary outcome measures

Survival, as well as toxicity and quality of life.

Overall trial start date

01/07/1999

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

375

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

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

Kerpernerstr. 62
Cologne
50937
Germany

Sponsor information

Organisation

German CLL Study Group (GCLLSG)

Sponsor details

Department of Internal Medicine I
University of Cologne
Cologne
50924
Germany
cllstudie@uk-koeln.de

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

CLL4 trial of the Geman CLL Study Group (GCLLSG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

MedacSchering Onkologie

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

Publication citations

Additional files

Editorial Notes