Long-term follow up of the CLL2007FMP trial evaluating fludarabine and cyclophosphamide in combination with either rituximab or alemtuzumab in previously untreated patients with chronic lymphocytic leukemia.

Feugier, Pierre;Aurran, Thérèse;Mahé, Béatrice;Letestu, Remi;Leprêtre, Stéphane;et.al.
(2018) Haematologica — Vol. 103, n° 7, p. e304-e306 (2018)

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Authors
  • Feugier, Pierre
    Author
  • Aurran, Thérèse
    Author
  • Mahé, Béatrice
    Author
  • Letestu, Remi
    Author
  • Author
  • Leprêtre, Stéphane
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Abstract
In fit chronic lymphocytic leukemia (CLL) patients without chromosome 17p deletion (del(17p)) or TP53 mutation, six cycles of FCR (fludarabine, cyclophosphamide, rituximab) provides the best progression-free survival (PFS) and overall survival (OS).1,2 In 2007, the French Innovative Leukemia Organization (FILO) group initiated the CLLFMP2007 study, a phase III trial in which fit patients with previously untreated CLL were randomized to six cycles of FCR or FCCam (fludarabine, cyclophosphamide, and alemtuzumab 30 mg subcutaneously on days 1-3 every 28 days). At the time, alemtuzumab, a humanized anti-CD52 monoclonal antibody, was one of the most active for treating CLL.3 Recruitment onto the CLLFMP2007 study was prematurely stopped because of excess toxicity in the FCCam arm, including 8 deaths, 4 from lymphoma and 4 from infection, in this cohort of 165 patients. We reported the initial results in 2012 with a median follow up of 38 months.4 Here, we provide the up-dated results with a median follow up of 76.4 months with particular attention to long-term outcome, toxicity, and minimal residual disease (MRD) data. [...]
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Feugier, P., Aurran, T., Mahé, B., Letestu, R., Nguyen-Khac, F., Cazin, B., Tournilhac, O., Maisonneuve, H., Casasnovas, O., Delmer, A., Leblond, V., Royer, B., Corront, B., Chevret, S., Delépine, R., Vaudaux, S., Van Den Neste, E., Béné, M.-C., Cymbalista, F., et al. (2018). Long-term follow up of the CLL2007FMP trial evaluating fludarabine and cyclophosphamide in combination with either rituximab or alemtuzumab in previously untreated patients with chronic lymphocytic leukemia. Haematologica, 103(7), e304-e306. https://doi.org/10.3324/haematol.2017.183350 (Original work published 2018)