Treatment of advanced, relapsed chronic lymphocytic leukemia (CLL) with fludarabine, miroxantrone and cyclophosphamide combination therapy with or without granulocyte colony stimulating factor (G-CSF)

ISRCTN	ISRCTN31486124
DOI	https://doi.org/10.1186/ISRCTN31486124
Protocol serial number	CLL6 protocol
Sponsor	German CLL Study Group (GCLLSG) (Germany)
Funder	Amgen (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Michael Hallek
Scientific

Kerpenerstr. 62
Cologne
50924
Germany

Phone	+49 221 478 4400
Email	michael.hallek@uk-koeln.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The prophylactic administration of G-CSF prevents the incidence of infections during relapse chemotherapy in chronic lymphocytic leukemia (CLL) patients
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Fludarabine, miroxantrone, cyclophosphamide and G-CSF
Primary outcome measure(s)	1. Incidence of severe and life threatening infections 2. Incidence of severe side effects 3. Remission rate
Key secondary outcome measure(s)	1. Overall survival 2. Progression free survival 3. Quality of remission
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	165
Key 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
Key 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
Date of first enrolment	06/08/1999
Date of final enrolment	30/09/2004

Kerpenerstr. 62

Cologne
50924
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan