Prognostic factors and early risk-adapted therapy in patients with chronic lymphocytic leukemia in Binet stage A
| ISRCTN | ISRCTN31378214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31378214 |
| Protocol serial number | CLL1 |
| Sponsor | German CLL Study Group (GCLLSG) (Germany) |
| Funders | German Cancer Aid (Deutsche Krebshilfe), Bonn (Germany), German Chronic Lymphocytic Leukemia Study Group (GCLLSG), Cologne (Germany) |
- Submission date
- 31/08/2005
- Registration date
- 06/10/2005
- Last edited
- 12/02/2020
- 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
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | - |
| Study objectives | 1. Identification of a group of high risk patients in Binet stage A 2. Evaluation of the efficacy of an early risk-adapted therapy in Binet stage A patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic Lymphocytic Leukemia (CLL) Binet stage A, untreated |
| Intervention | 1. Intervention: randomised treatment with fludarabine (25 mg/m^2, days one to five, every 28 days, for a maximum of six courses) in high risk patients 2. Control: Watch and wait |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fludarabine |
| Primary outcome measure(s) |
Progression-free survival |
| Key secondary outcome measure(s) |
1. Overall survival |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 320 |
| Total final enrolment | 539 |
| Key inclusion criteria | 1. Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) in Binet stage A 2. Initial diagnosis within the last three years 3. No previous therapy 4. Age between 18 and 75 years 5. Eastern Cooperative Oncology Group (ECOG) status zero to two 6. Signed informed consent |
| Key exclusion criteria | 1. Autoimmune cytopenia 2. Severe concommitant disease 3. Concomitant secondary neoplasia 4. Participation in another clinical trial |
| Date of first enrolment | 01/07/1997 |
| 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 | 01/04/2020 | 12/02/2020 | Yes | No |
Editorial Notes
12/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
