Condition category
Cancer
Date applied
30/06/2005
Date assigned
11/10/2005
Last edited
09/11/2009
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
+49 221 478 4400
michael.hallek@uk-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CLL6 protocol

Study information

Scientific title

Acronym

Study hypothesis

The prophylactic administration of G-CSF prevents the incidence of infections during relapse chemotherapy in chronic lymphocytic leukemia (CLL) 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

Relapsed B-cell chronic lymphocytic leukemia (B-CLL)

Intervention

Fludarabine 25 mg/m^2 day 1-3, mitoxantrone 8 mg/m^2 day 1, cyclophosphamide 200 mg/m^2 day 1-3, repeated every 28 days, maximum 6 courses.

Arm A with G-CSF: 5 µg/kg bodyweight/day subcutaneously (sc) beginning on day +6 until neutrophil recovery above 1500/µl.
Arm B without G-CSF.

Intervention type

Drug

Phase

Not Specified

Drug names

Fludarabine, miroxantrone, cyclophosphamide and G-CSF

Primary outcome measures

1. Incidence of severe and life threatening infections
2. Incidence of severe side effects
3. Remission rate

Secondary outcome measures

1. Overall survival
2. Progression free survival
3. Quality of remission

Overall trial start date

06/08/1999

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. B-cell chronic lymphocytic leukemia (B-CLL)
2. Binet stage C, Binet stage B with treatment indication
3. Maximum of 3 previous treatment regimen
4. Age 18-70 years
5. Life expectancy more than 6 months
6. Eastern Cooperative Oncology Group (ECOG) 0-3
7. Normal cardiac function
8. Signed inform consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

165

Participant exclusion criteria

1. Severe organ dysfunction
2. Autoimmune haemolytic anaemia (AIHA)
3. More than 3 chemotherapy regimens
4. Concomitant or previous neoplasm
5. Non-response to previous treatment with Fludarabine + Cyclophosphamide, Fludarabine + Mitoxantrone, Fludarabine + Epirubicine

Recruitment start date

06/08/1999

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) (Germany)

Sponsor details

Herderstr. 52-54
Cologne
50931
Germany
+49 221 478 3988
cllstudie@uk-koeln.de

Sponsor type

Research organisation

Website

http://www.dcllsg.de

Funders

Funder type

Industry

Funder name

Amgen (USA)

Alternative name(s)

Amgen Inc., Applied Molecular Genetics Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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