A randomised comparison of chlorambucil, fludarabine and fludarabine plus cyclophosphamide
| ISRCTN | ISRCTN58585610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58585610 |
| EudraCT/CTIS number | 2004-000105-21 |
| ClinicalTrials.gov number | NCT00004218 |
| Secondary identifying numbers | LRF CLL4 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 hypothesis | 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. |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chlorambucil, fludarabine, fludarabine, cyclophosphamide |
| Primary outcome measure | Survival |
| Secondary outcome measures | 1. Response to therapy 2. Duration of response 3. Toxicity 4. Quality of life |
| Overall study start date | 01/02/1999 |
| Overall study end date | 30/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 750 (initially 500) |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/02/1999 |
| Recruitment end date | 30/10/2004 |
Locations
Countries of recruitment
- Argentina
- Croatia
- England
- Greece
- Ireland
- Italy
- New Zealand
- Russian Federation
- United Kingdom
Study participating centre
Section of Haemato-Oncology
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
c/o Professor D Catovsky
Section of Haemato-Oncology
Brookes Lawley Building
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 (0)20 8722 4114 |
|---|---|
| daniel.catovsky@icr.ac.uk | |
| Website | http://www.icr.ac.uk/ |
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Charity
Leukaemia Research Fund (UK)
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? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| 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 |
Editorial Notes
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
