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| A randomised comparison of Chlorambucil, Fludarabine and Fludarabine plus Cyclophosphamide |
| Source of record | UK Trials |
| ISRCTN | ISRCTN58585610 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LRF CLL4 |
| Public title | A randomised comparison of Chlorambucil, Fludarabine and Fludarabine plus Cyclophosphamide |
| Scientific title | |
| Acronym | CLL 4 |
| Disease/condition/study domain | Chronic lymphocytic leukaemia (CLL) |
| 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: survival, response to therapy, duration of response, toxicity and quality of life. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | 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 Feb 01. |
| Countries of trial | United Kingdom, Argentina, Croatia, Greece, Ireland, Italy, New Zealand, Russia |
| Participants - 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 |
| Participants - 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. |
| Patient information material | |
| Anticipated start date | 01/02/1999 |
| Anticipated end date | 30/10/2004 |
| Status of trial | Completed |
| Target number of participants | 750 (initially 500) |
| Interventions | 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. |
| Primary outcome measure(s) | Survival |
| Secondary outcome measure(s) | 1. Response to therapy 2. Duration of response 3. Toxicity 4. Quality of life |
| Trial website | http://www.icr.ac.uk/research/research_sections/haemato_oncology/4448.shtml |
| Sources of funding | Leukaemia Research Fund (UK) |
| Sponsor name | Institute of Cancer Research (UK) |
| Sponsor details | c/o Professor D Catovsky Section of Haemato-Oncology Brookes Lawley Building 15 Cotswold Road Sutton United Kingdom SM2 5NG |
| Sponsor telephone | +44 (0)20 8722 4114 |
| Sponsor fax | +44 (0)20 7795 0310 |
| Sponsor email | daniel.catovsky@icr.ac.uk |
| Sponsor website | http://www.icr.ac.uk/ |
| Contact name | Prof D Catovsky |
| Contact details | Section of Haemato-Oncology Institute of Cancer Research Brookes Lawley Building 15 Cotswold Road Sutton United Kingdom SM2 5NG |
| Contact telephone | +44 (0)20 8722 4114 |
| Contact fax | +44 (0)20 7795 0310 |
| Contact email | daniel.catovsky@icr.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN58585610 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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