A randomised comparison of chlorambucil, fludarabine and fludarabine plus cyclophosphamide
| ISRCTN | ISRCTN58585610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58585610 |
| ClinicalTrials.gov (NCT) | NCT00004218 |
| Clinical Trials Information System (CTIS) | 2004-000105-21 |
| Protocol serial number | LRF CLL4 |
| Sponsor | Institute of Cancer Research (UK) |
| Funder | Leukaemia Research Fund (UK) |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 17/10/2018
- 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 D Catovsky
Scientific
Scientific
Section of Haemato-Oncology
Institute of Cancer Research
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 (0)20 8722 4114 |
|---|---|
| daniel.catovsky@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Conventional therapy with chlorambucil versus fludarabine, used alone or in a novel combination with cyclophosphamide: a randomised controlled trial |
| Study acronym | CLL 4 |
| Study objectives | This study will compare conventional therapy with chlorambucil versus the new agent fludarabine, used alone or in a novel combination with cyclophosphamide. End points of the trial will be: 1. Survival 2. Response to therapy 3. Duration of response 4. Toxicity 5. Quality of life |
| Ethics approval(s) | South Thames MREC initially approved of this trial in 1998 (ref. no: MREC 98/1/101). An amendment to the protocol was accepted on 27th February 2001. |
| Health condition(s) or problem(s) studied | Chronic lymphocytic leukaemia (CLL) |
| Intervention | Patients will be randomised between chlorambucil versus fludarabine based treatment. Half of the patients randomised to fludarabine will be randomised between fludarabine plus cyclophosphamide and fludarabine alone. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chlorambucil, fludarabine, fludarabine, cyclophosphamide |
| Primary outcome measure(s) |
Survival |
| Key secondary outcome measure(s) |
1. Response to therapy |
| Completion date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 750 |
| Key inclusion criteria | 1. Patients are diagnosed with B-cell chronic lymphocytic leukaemia 2. They have not previously been treated 3. They have been diagnosed by a persistent lymphocytosis and bone marrow infiltration of at least 40% and require treatment 4. They are classified as having stage A progressive, stage B or stage C disease using the International Binet Staging System 5. They have given informed consent |
| Key exclusion criteria | 1. Patients with other life-threatening diseases 2. Patients unable or unwilling to give informed consent 3. Renal failure (creatinine clearance less than 30 ml/min) 4. Hepatic enzymes and bilirubin greater than twice the upper limit of normal, unless due to CLL 5. Pregnant women or women at risk of pregnancy 6. Patients who for other reasons are not expected to complete the study 7. Patients with a diagnosis other than CLL after central review of markers and morphology |
| Date of first enrolment | 01/02/1999 |
| Date of final enrolment | 30/10/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
- Argentina
- Croatia
- Greece
- Ireland
- Italy
- New Zealand
- Russian Federation
Study participating centre
Section of Haemato-Oncology
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
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 of assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia | 21/07/2007 | Yes | No | |
| Results article | results on the scan of nonsynonymous SNPs in CLL4 trial patients for the identification of genetic variants influencing prognosis | 01/02/2008 | Yes | No | |
| Results article | results on the prognostic significance of a positive direct antiglobulin test in chronic lymphocytic leukemia | 15/02/2008 | Yes | No | |
| Results article | results on baseline health-related quality of life | 01/12/2008 | Yes | No | |
| Results article | results of identification of prognostic makers | 01/10/2010 | Yes | No | |
| Results article | results of relative importance of prognostic makers | 01/10/2010 | Yes | No | |
| Plain English results | No | Yes | |||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
