Condition category
Cancer
Date applied
30/06/2005
Date assigned
11/10/2005
Last edited
16/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dcllsg.de/en/cll5/index.php

Contact information

Type

Scientific

Primary contact

Prof Michael Hallek

ORCID ID

Contact details

Kerpenerstr. 62
Cologne
50924
Germany
+49 221 4784400
michael.hallek@uk-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00262795

Protocol/serial number

CLL5 protocol

Study information

Scientific title

Acronym

Study hypothesis

Superiority of fludarabine compared to chlorambucil in elderly 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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

B-Chronic Lymphocytic Leukemia (CLL)

Intervention

Fludarabine 25 mg/m^2 for five days intravenously, q 28 days, maximum of six courses.
Chlorambucil 0.4 mg/kg bodyweight with increasing of the dose up to 0.8 mg/kg bodyweight, q 15 days, maximum 12 months.

Intervention type

Drug

Phase

Not Specified

Drug names

Fludarabine and chlorambucil

Primary outcome measures

Progression free survival, overall survival, duration of remission, quality of remission.

Secondary outcome measures

1. Toxicity
2. Quality of life

Overall trial start date

01/07/1999

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. B-CLL
2. Binet stage C or Binet stage B with symptoms, which require therapy, or Binet stage A with severe B-symptoms
3. Age 66 - 79 years
4. No previous treatment
5. Signed informed-consent
6. Life expectancy of more than six months
7. Eastern Cooperative Oncology Group (ECOG) status zero, one or two

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Severe organ dysfunction
2. Concomitant or previous neoplasm

Recruitment start date

01/07/1999

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)

Sponsor details

Herderstr. 52-54
Cologne
50931
Germany
+49 221 4783988
cllstudie@uk-koeln.de

Sponsor type

Research organisation

Website

http://www.dcllsg.de

Funders

Funder type

Industry

Funder name

German Cancer Aid (Deutsche Krebshilfe) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medac Schering Onkologie GmBH (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19605849

Publication citations

  1. Results

    Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhöfer N, Rohrberg R, Söling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Döhner H, Emmerich B, Hallek M, , First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia., Blood, 2009, 114, 16, 3382-3391, doi: 10.1182/blood-2009-02-206185.

Additional files

Editorial Notes