Condition category
Cancer
Date applied
31/08/2005
Date assigned
06/10/2005
Last edited
06/11/2009
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

Kerpenerstr. 62
Cologne
50924
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CLL1

Study information

Scientific title

Acronym

Study hypothesis

1. Identification of a group of high risk patients in Binet stage A
2. Evaluation of the efficacy of an early risk-adapted therapy in Binet stage A patients

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

Treatment

Patient information sheet

Condition

Chronic Lymphocytic Leukemia (CLL) Binet stage A, untreated

Intervention

1. Intervention: randomised treatment with fludarabine (25 mg/m^2, days one to five, every 28 days, for a maximum of six courses) in high risk patients
2. Control: Watch and wait

Intervention type

Drug

Phase

Not Specified

Drug names

Fludarabine

Primary outcome measures

Progression-free survival

Secondary outcome measures

1. Overall survival
2. Quality of life
3. Incidence of infections

Overall trial start date

01/07/1997

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) in Binet stage A
2. Initial diagnosis within the last three years
3. No previous therapy
4. Age between 18 and 75 years
5. Eastern Cooperative Oncology Group (ECOG) status zero to two
6. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

1. Autoimmune cytopenia
2. Severe concommitant disease
3. Concomitant secondary neoplasia
4. Participation in another clinical trial

Recruitment start date

01/07/1997

Recruitment end date

30/09/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Kerpenerstr. 62
Cologne
50924
Germany

Sponsor information

Organisation

German CLL Study Group (GCLLSG) (Germany)

Sponsor details

Department of Internal Medicine I
University of Cologne
Cologne
50924
Germany
+49 221 4783988
cll-studie@uk-koeln.de

Sponsor type

Research organisation

Website

http://www.dcllsg.de

Funders

Funder type

Charity

Funder name

German Cancer Aid (Deutsche Krebshilfe), Bonn (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Chronic Lymphocytic Leukemia Study Group (GCLLSG), Cologne (Germany)

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