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Oral cladribine for B-cell chronic lymphocytic leukaemia: Report of a phase II trial with a 3-d, 3-weekly schedule in untreated and pretreated patients, and a long-term follow-up of 126 previously untreated patients

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Karlsson, Karin Stromberg, Mats Liliemark, Jan Delannoy, André [UCL] Johnson, S.A.N. Juliusson, Gunnar

A phase II study was undertaken to evaluate the efficacy and toxicity of a new schedule of cladribine administration (10 mg/m(2) orally daily for 3 d every 3 weeks) in 107 patients with B-cell chronic lymphocytic leukaemia (CLL). To minimize toxicity. treatment withdrawal criteria were defined. The results of the h 3 previously untreated patients were retrospectively compared with 0 3 from an earlier study using a 5-d monthly, schedule. The compiled data were analysed for prognostic factors for survival. No significant difference regarding response were seen in the two cohorts of the 126 previously untreated patients. The complete response (CR), nodular partial response (nPR) and partial response (PR) rates were 15% 21% and 41%. Quality of response had no impact on survival. The 3- and 5-year overall survival for previously untreated patients was 73% and 58%, respectively, with a median follow-up of 54 months, Pretreatment haemoglobin < 11.0 g/dl and elevated beta-2-microglobulin had a negative influence oil Survival. Major infections occurred in 21% of patients in the 3-d study compared with 35% in the 5-d study. The overall response (OR) and CR rates in the 40 previously treated patients were 34% and 5% respectively, Median overall survival was 24 months and median progression-free survival for responding patients was 14 months. Cladribine used as a single agent is an effective treatment with an acceptable safety profile for pretreated and untreated B-CLL. The achievement of complete remission was not it prerequisite for long-term survival.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2002
Language Anglais
Journal information "British Journal of Haematology" - Vol. 116, no. 3, p. 538-548 (2002)
Peer reviewed yes
Publisher Blackwell Publishing Ltd (Oxford)
issn 0007-1048
e-issn 1365-2141
Publication status Publié
Affiliation UCL - (SLuc) Service d'hématologie
Keywords cladribine ; chronic lymphocytic leukaemia ; infection ; side-effects ; treatment
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Bibliographic reference Karlsson, Karin ; Stromberg, Mats ; Liliemark, Jan ; Delannoy, André ; Johnson, S.A.N. ; et. al. Oral cladribine for B-cell chronic lymphocytic leukaemia: Report of a phase II trial with a 3-d, 3-weekly schedule in untreated and pretreated patients, and a long-term follow-up of 126 previously untreated patients. In: British Journal of Haematology, Vol. 116, no. 3, p. 538-548 (2002)
Permanent URL http://hdl.handle.net/2078.1/42380