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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02757147 |
| Secondary identifying numbers | CLL-8 |
- Submission date
- 21/11/2003
- Registration date
- 12/12/2003
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Hallek
Scientific
Scientific
Direktor der Klinik I für Innere Medizin
Universitaet zu Koeln
Joseph-Stelzmann-Str. 9
Koeln
D-50924
Germany
| Phone | +49 (0)221 478 4400 |
|---|---|
| michael.hallek@uni-koeln.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | CLL-8 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2003 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 760 |
| Total final enrolment | 552 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Direktor der Klinik I für Innere Medizin
Koeln
D-50924
Germany
D-50924
Germany
Sponsor information
German CLL Study Group - GCLLSG (Germany)
Research organisation
Research organisation
Department of Internal Medicine I
University of Cologne
Cologne
50924
Germany
| Phone | +49 (0)221 478 3988 |
|---|---|
| cllstudie@uk-koeln.de |
Funders
Funder type
Industry
Hoffmann-La Roche AG (Protocol ML17102)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2010 | 23/09/2021 | Yes | No |
Editorial Notes
23/09/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
