Condition category
Cancer
Date applied
21/11/2003
Date assigned
12/12/2003
Last edited
14/05/2007
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

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes