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
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