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Blood, 1 January 2005, Vol. 105, No. 1, pp. 397-404.
Prepublished online as a Blood First Edition Paper on April 29, 2004; DOI 10.1182/blood-2004-01-0298.


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Submitted January 30, 2004
Accepted April 7, 2004

Autografting for younger patients with chronic lymphocytic leukaemia is safe and achieves a high percentage of molecular responses. Results of the MRC Pilot Study

Donald W Milligan*, Savio Fernandes, Ranjit Dasgupta, Faith E Davies, Estella Matutes, Christopher D Fegan, Christopher McConkey, J A Child, David Cunningham, Gareth J Morgan, and Daniel Catovsky

Haematology, Birmingham Heartlands Hospital, Birmingham, United Kingdom
Haematology, Leeds General Infirmary, Leeds, United Kingdom
Haematology, Royal Marsden Hospital, London, United Kingdom
CRUK Institute for Cancer Studies, University of Birmingham, Birmingham, United Kingdom

* Corresponding author; email: d.w.milligan{at}bham.ac.uk.

We have assessed autologous stem cell transplantation after treatment with fludarabine, in previously untreated patients with CLL. This study is the first to enrol previously untreated patients and follow them prospectively. The initial response rate to fludarabine was 82% (94/115). Stem cell mobilisation was attempted in 88 patients and was successful in 67% (59/88). Overall 56% (65/115) of patients entered into the study proceeded to autologous transplant. The early transplant related mortality was 1.5% (1/65). The number of patients in complete remission after transplant increased from 37% (24/65) to 74% (48/65), and 26/41 (63%) patients who were not in complete remission at the time of their transplant achieved a complete remission post transplant. The five-year overall and disease-free survival from transplantation was 77.5% (CI 57.2, 97.8%) and 51.5% (CI 33.2, 69.8%) respectively. None of the variables examined at study entry were found to be predictors of either overall or disease-free survival. 16 of 20 evaluable patients achieved a molecular remission on a polymerase chain reaction (PCR) for immunoglobulin heavy chain gene re-arrangements in the first six months following their transplant. Detectable molecular disease by PCR was highly predictive of disease recurrence. It is of concern that 5/65 (8%) patients developed post-transplant AML/MDS.


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