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| The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN69559570 |
| Date ISRCTN assigned | 02/05/2001 |
| Local reference number(s) | G0001160 |
| Public title | The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial |
| Scientific title | |
| Acronym | MRC CLL5 |
| Disease/condition/study domain | Leukaemia |
| Study hypothesis | This is a prospective randomised phase III trial designed to determine the outcome of autologous SCT compared to no further treatment at present in patients with high risk CLL who have reached a complete remission (CR), a very good partial remission (VGPR) or a nodular partial remission (NPR) after first or second line therapy. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. B CLL CD5+/CD23+ 2. There is no upper age limit but patients must be judged physically able to withstand high-dose chemotherapy and the suitability of this treatment may be discussed with the Transplant Centre 3. Binet stage (at initiation of first line treatment) B, C, or progressive A 4. Complete Remission (CR) or Very Good Partial Remission (VGPR) or Nodular Partial Remission (NPR) assessed by bone marrow biopsy after first or second line treatment 5. Written informed consent |
| Participants - exclusion criteria | 1. Age less than 18 2. WHO Performance status less than 2 3. Any T-cell leukaemia, NHL, Richter syndrome, mantle cell lymphoma, PLL 4. HIV seropositivity. 5. Inadequate renal or liver function, i.e. creatinine and bilirubin less than 1.5 times the upper limit of normal 6. Severe heart failure, requiring diuretics or ejection fraction of less than 50% 7. Severe concomitant neurological or psychiatric disease 8. Pregnancy/lactation 9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be discussed with the patient before registration in the trial. 10. Patients will be excluded if an allograft is planned |
| Patient information material | |
| Anticipated start date | 17/01/2002 |
| Anticipated end date | 16/01/2008 |
| Status of trial | Completed |
| Target number of participants | 270 |
| Interventions | In this trial, younger patients with chronic lymphocytic leukaemia who are thought to be medically fit for autologous transplantation will be treated to maximal response with standard chemotherapy. Patients will then be randomised to undergo stem cell mobilisation followed by a cyclophosphamide/total body irradiation conditioned autograft. Purging of the stem cell product is optional. Those patients not randomised to have an autograft will have the option of stem cell storage to be used at a later date. |
| Primary outcome measure(s) | Primary endpoints: 1. Progression free survival from randomisation 2. Overall survival from randomisation |
| Secondary outcome measure(s) | Secondary endpoints: 1. Time to disease requiring therapy from time of remission 2. Quality of life 3. Feasibility of first line versus late stem cell transplant 4. Feasibility of peripheral blood mobilisation |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Heart of England NHS Foundation Trust (UK) |
| Sponsor details | Birmingham Heartlands Hospital Bordesley Green East Birmingham United Kingdom B9 5SS |
| Sponsor website | http://www.heartofengland.nhs.uk |
| Contact name | Dr DW Milligan |
| Contact details | Department of Haematology Birmingham Heartlands Hospital Bordesley Green East Birmingham United Kingdom B9 5SS |
| Contact telephone | +44 (0)121 424 3699 |
| Contact fax | +44 (0)121 766 7530 |
| Contact email | d.w.milligan@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN69559570 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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