The value of autografting younger patients with high risk chronic lymphocytic leukaemia (CLL). A randomised phase III intergroup trial

INTERVENTION: 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. CONDITION: Leukaemia ; Cancer ; Leukaemia PRIMARY OUTCOME: Primary endpoints:; 1. Progression free survival from randomisation; 2. Overall survival from randomisation SECONDARY OUTCOME: 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 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