Treatment of elderly patients with advanced chronic lymphocytic leukemia (CLL) with fludarabine versus chlorambucil
| ISRCTN | ISRCTN36294212 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36294212 |
| ClinicalTrials.gov (NCT) | NCT00262795 |
| Protocol serial number | CLL5 protocol |
| Sponsor | German CLL Study Group (GCLLSG) |
| Funders | German Cancer Aid (Deutsche Krebshilfe) (Germany), Medac Schering Onkologie GmBH (Germany) |
- Submission date
- 30/06/2005
- Registration date
- 11/10/2005
- Last edited
- 16/09/2009
- 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
Kerpenerstr. 62
Cologne
50924
Germany
| Phone | +49 221 4784400 |
|---|---|
| michael.hallek@uk-koeln.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Superiority of fludarabine compared to chlorambucil in elderly patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | B-Chronic Lymphocytic Leukemia (CLL) |
| Intervention | Fludarabine 25 mg/m^2 for five days intravenously, q 28 days, maximum of six courses. Chlorambucil 0.4 mg/kg bodyweight with increasing of the dose up to 0.8 mg/kg bodyweight, q 15 days, maximum 12 months. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fludarabine and chlorambucil |
| Primary outcome measure(s) |
Progression free survival, overall survival, duration of remission, quality of remission. |
| Key secondary outcome measure(s) |
1. Toxicity |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. B-CLL 2. Binet stage C or Binet stage B with symptoms, which require therapy, or Binet stage A with severe B-symptoms 3. Age 66 - 79 years 4. No previous treatment 5. Signed informed-consent 6. Life expectancy of more than six months 7. Eastern Cooperative Oncology Group (ECOG) status zero, one or two |
| Key exclusion criteria | 1. Severe organ dysfunction 2. Concomitant or previous neoplasm |
| Date of first enrolment | 01/07/1999 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Kerpenerstr. 62
Cologne
50924
Germany
50924
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/10/2009 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
