Leukaemia Cancer Leukaemia
Conditions
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. P
Sponsors
Heart of England NHS Foundation Trust (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: 1. Progression free survival from randomisation 2. Overall survival from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, France, Germany, Switzerland, United Kingdom
Outcome results
None listed