Contact information
Type
Scientific
Primary contact
Prof Michael Hallek
ORCID ID
Contact details
Direktor der Klinik I für Innere Medizin
Universitaet zu Koeln
Joseph-Stelzmann-Str. 9
Koeln
D-50924
Germany
+49 (0)221 478 4400
michael.hallek@uni-koeln.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CLL-8
Study information
Scientific title
Acronym
CLL-8
Study hypothesis
The objective of this study is to determine the value of immunochemotherapy with FCR in comparison with chemotherapy with FC alone in the first-line therapy of B-CLL. The study is to answer the following questions:
1. Is combined immunochemotherapy with FCR superior to chemotherapy with FC alone in the first-line therapy of B-CLL?
2. Is combined immunochemotherapy with FCR a safe alternative to FC chemotherapy alone with regards to the adverse effects
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Chronic lymphocytic leukaemia (CLL)
Intervention
Patients will be randomised between combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) (Arm A) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone (Arm B).
Intervention type
Drug
Phase
Phase III
Drug names
Fludarabine, Cyclophosphamide, Rituximab, Cyclophosphamide
Primary outcome measure
Progression-free survival (PFS)
Secondary outcome measures
1. Event-free survival
2. Overall survival
3. Disease-free survival
4. Duration of remission
5. Time to new CLL treatment or death
6. Rates of molecular, complete and partial remission
7. Response rates and survival times in biological subgroups
8. Rates of treatment-related adverse effects
9. Pharmacoeconomic impact
10. Quality of life
Overall trial start date
01/07/2003
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Confirmed diagnosis of B-CLL according to National Cancer Institute (NCI)/German CLL Study Group (GCLLSG) criteria
2. Need for treatment
3. Age ≥18 years
4. Life expectancy >6 months
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
6. Patient's written informed consent
7. Willingness to contraception for the entire duration of the treatment and 2 months thereafter
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
760
Participant exclusion criteria
1. Manifest autoimmune cytopaenias including Coombs-positive autoimmune haemolytic anaemia
2. Active second malignancy requiring treatment (except basal cell carcinoma or malignant tumour treated curatively by surgery)
3. Prior chemotherapy and/or radiotherapy
4. Pregnancy, nursing
5. Concomitant disease requiring prolonged use of glucocorticoids (>1 month)
6. Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the study drugs
7. Active bacterial, viral or fungal infection
8. Creatinine clearance <70 ml/min
9. Total bilirubin >2 fold of upper normal limit
10. Total cumulative illness rating scale (CIRS) score >6
11. Cerebral dysfunction, legal incapacity
12. Richter's syndrome
Recruitment start date
01/07/2003
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Direktor der Klinik I für Innere Medizin
Koeln
D-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 (0)221 478 3988
cllstudie@uk-koeln.de
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Hoffmann-La Roche AG (Protocol ML17102)
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
Basic results (scientific)
Publication list