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02 September 2010
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| [ Print-friendly version ] |
| The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial |
| ISRCTN | ISRCTN69559570 |
| ClinicalTrials.gov identifier | |
| 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 |
| Serial number at source | G0001160 |
| 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.
The MRC CLL5 protocol is avaialble on http://www.ebmt.org/5WorkingParties/CLWP/CLL5/MRC_CLL5_protocol.pdf |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom, International |
| Disease/condition/study domain | Leukaemia |
| 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 |
| Anticipated start date | 17/01/2002 |
| Anticipated end date | 16/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Added 09/09/09: Total 270 - UK anticipated to contribute approximately 125 patients |
| 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 (MRC) (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr DW Milligan |
| Address |
Department of Haematology
Birmingham Heartlands Hospital Bordesley Green East |
| City/town | Birmingham |
| Zip/Postcode | B9 5SS |
| Country | United Kingdom |
| Tel | +44 (0)121 424 3699 |
| Fax | +44 (0)121 766 7530 |
| d.w.milligan@bham.ac.uk | |
| Sponsor | Heart of England NHS Foundation Trust (UK) |
| Address |
Birmingham Heartlands Hospital
Bordesley Green East |
| City/town | Birmingham |
| Zip/Postcode | B9 5SS |
| Country | United Kingdom |
| Sponsor website: | http://www.heartofengland.nhs.uk |
| Date applied | 02/05/2001 |
| Last edited | 09/09/2009 |
| Date ISRCTN assigned | 02/05/2001 |
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| © 2010 ISRCTN unless otherwise stated. | |
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