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    Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia.

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    Authors
    Wendtner, C
    Hillmen, P
    Mahadevan, D
    Bühler, A
    Uharek, L
    Coutré, S
    Frankfurt, O
    Bloor, Adrian
    Bosch, F
    Furman, R
    Kimby, E
    Gribben, J
    Gobbi, M
    Dreisbach, L
    Hurd, D
    Sekeres, M
    Ferrajoli, A
    Shah, S
    Zhang, J
    Moutouh-de Parseval, L
    Hallek, M
    Heerema, N
    Stilgenbauer, S
    Chanan-Khan, A
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    Affiliation
    Department I of Internal Medicine, Center of Integrated Oncology (CIO), CECAD, University of Cologne, Cologne, Germany. clemens.wendtner@uni-koeln.de
    Issue Date
    2012-03
    
    Metadata
    Show full item record
    Abstract
    Based on clinical activity in phase 2 studies, lenalidomide was evaluated in a phase 2/3 study in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Following tumor lysis syndrome (TLS) complications, the protocol was amended to a phase 1 study to identify the maximum tolerated dose-escalation level (MTDEL). Fifty-two heavily pretreated patients, 69% with bulky disease and 48% with high-risk genomic abnormalities, initiated lenalidomide at 2.5 mg/day, with dose escalation until the MTDEL or the maximum assigned dose was attained. Lenalidomide was safely titrated to 20 mg/day; the MTDEL was not reached. Most common grade 3-4 adverse events were neutropenia and thrombocytopenia; TLS was mild and rare. The low starting dose and conservative dose escalation strategy resulted in six partial responders and 30 patients obtaining stable disease. In summary, lenalidomide 2.5 mg/day is a safe starting dose that can be titrated up to 20 mg/day in patients with CLL.
    Citation
    Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. 2012, 53 (3):417-23 Leuk Lymphoma
    Journal
    Leukemia & Lymphoma
    URI
    http://hdl.handle.net/10541/230173
    DOI
    10.3109/10428194.2011.618232
    PubMed ID
    21879809
    Type
    Article
    Language
    en
    ISSN
    1029-2403
    ae974a485f413a2113503eed53cd6c53
    10.3109/10428194.2011.618232
    Scopus Count
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