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 number | NCT00262795 |
| Secondary identifying numbers | CLL5 protocol |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Superiority of fludarabine compared to chlorambucil in elderly patients |
| Ethics approval(s) | Not provided at time of registration |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fludarabine and chlorambucil |
| Primary outcome measure | Progression free survival, overall survival, duration of remission, quality of remission. |
| Secondary outcome measures | 1. Toxicity 2. Quality of life |
| Overall study start date | 01/07/1999 |
| Overall study end date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 200 |
| Participant 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 |
| Participant exclusion criteria | 1. Severe organ dysfunction 2. Concomitant or previous neoplasm |
| Recruitment start date | 01/07/1999 |
| Recruitment end date | 30/09/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Kerpenerstr. 62
Cologne
50924
Germany
50924
Germany
Sponsor information
German CLL Study Group (GCLLSG)
Research organisation
Research organisation
Herderstr. 52-54
Cologne
50931
Germany
| Phone | +49 221 4783988 |
|---|---|
| cllstudie@uk-koeln.de | |
| Website | http://www.dcllsg.de |
Funders
Funder type
Industry
German Cancer Aid (Deutsche Krebshilfe) (Germany)
No information available
Medac Schering Onkologie GmBH (Germany)
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 | results | 15/10/2009 | Yes | No |
