| Source of record | Leukaemia Research Fund |
| ISRCTN | ISRCTN58585610 |
| Serial number at source | 58585610 |
| Other organisations' reference numbers | N0083043441, M0035043715, N0176045416, N0025049043, N0411051102 (NRR); MRC CLL4 (UKCCCR) |
| Title of trial/grant title | A randomised comparison of Chlorambucil, Fludarabine and Fludarabine plus Cyclophosphamide |
| Acronym | CLL 4 |
| Disease or condition | Chronic Lymphocytic Leukaemia (CLL) |
| Current status of trial | Open |
| Patient information material | Patient Information Sheets are available as Word97 documents or PDF-files from http://leuktrials.uwcm.ac.uk/trials/cll/current/cll-4/forms/default.htm and http://www.icr.ac.uk/haemcyto/CLL4/ |
| Topic/hypothesis/clinical objectives | The objectives of this trial are to ascertain whether Fludarabine prolongs the survival of previously untreated patients when compared with Chlorambucil, and whether the combination of Cyclophosphamide/Fludarabine offers additional survival benefit. In addition, the response rates, duration of remissions achieved with the three treatment modalities and associated toxicity are being compared. Further objectives are the investigation of quality of life issues, the examination of the prognostic value of four genetic markers and the determination of the usefulness of the information provided by the DiSC assay in improving response rate and survival in relapsed or non-responding patients. |
| Design/methodology | Randomised controlled trial |
| Eligibility criteria - inclusion | Patients are eligible for CLL 4 if:
1. They 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 |
| Eligibility criteria - exclusion | Patients are not eligible for CLL 4 if:
1. They suffer from any other life-threatening disease
2. They present with renal failure or their hepatic enzymes and bilirubin levels are significantly raised caused by anything other than CLL
3. They are pregnant or at risk of pregnancy
4. They are diagnosed with something other than CLL after central review of markers and morphology
5. They are not expected to complete the study for other reasons |
| Randomised 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. |
| Sources of funding | Leukaemia Research Fund |
| Contact name(s) | Professor D Catovsky |
| Contact details | Academic Department of Haematology and Cytogenetics
Royal Marsden Hospital
203 Fulham Road
London
SW3 6JJ
UK
Tel: +44 (0)20 7808 2875
Fax: +44 (0)20 7351 6420
Email: d.catovsky@icr.ac.uk |
| Further information | This trial register was updated in October 2003. Further information can be obtained from the lead researcher named above, or from the National Cancer Research Network database. |
| Date live in mRCT | 03 August 2004 |
