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11 February 2012
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| [ Print-friendly version ] |
| Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia |
| ISRCTN | ISRCTN02757147 |
| ClinicalTrials.gov identifier | |
| Public title | Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FC-R) versus chemotherapy with Fludarabine and Cyclophosphamide (FC) alone in patients with previously untreated chronic lymphocytic leukaemia |
| Scientific title | |
| Acronym | CLL-8 |
| Serial number at source | 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 |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Chronic lymphocytic leukaemia (CLL) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/07/2003 |
| Anticipated end date | 30/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 760 |
| Interventions | 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). |
| Primary outcome measure(s) | Progression-free survival (PFS) |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Hoffmann-La Roche AG (Protocol ML17102) |
| Trial website | |
| Publications | |
| Contact name | Prof Michael Hallek |
| Address |
Direktor der Klinik I für Innere Medizin
Universitaet zu Koeln Joseph-Stelzmann-Str. 9 |
| City/town | Koeln |
| Zip/Postcode | D-50924 |
| Country | Germany |
| Tel | +49 (0)221 478 4400 |
| Fax | +49 (0)221 478 5455 |
| michael.hallek@uni-koeln.de | |
| Sponsor | German CLL Study Group - GCLLSG (Germany) |
| Address |
Department of Internal Medicine I
University of Cologne |
| City/town | Cologne |
| Zip/Postcode | 50924 |
| Country | Germany |
| Tel | +49 (0)221 478 3988 |
| Fax | +49 (0)221 478 86886 |
| cllstudie@uk-koeln.de | |
| Date applied | 21/11/2003 |
| Last edited | 14/05/2007 |
| Date ISRCTN assigned | 12/12/2003 |
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| © 2012 ISRCTN unless otherwise stated. | |
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