TY - JOUR
T1 - Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia
AU - Wendtner, Clemens Martin
AU - Hillmen, Peter
AU - Mahadevan, Daruka
AU - Bhler, Andreas
AU - Uharek, Lutz
AU - Coutré, Steven
AU - Frankfurt, Olga
AU - Bloor, Adrian
AU - Bosch, Francesc
AU - Furman, Richard R.
AU - Kimby, Eva
AU - Gribben, John G.
AU - Gobbi, Marco
AU - Dreisbach, Luke
AU - Hurd, David D.
AU - Sekeres, Mikkael A.
AU - Ferrajoli, Alessandra
AU - Shah, Sheetal
AU - Zhang, Jennie
AU - Moutouh-De Parseval, Laure
AU - Hallek, Michael
AU - Heerema, Nyla A.
AU - Stilgenbauer, Stephan
AU - Chanan-Khan, Asher A.
N1 - Funding Information:
Th is trial was funded by Celgene Corporation.
PY - 2012/3
Y1 - 2012/3
N2 - 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 34 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.
AB - 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 34 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.
KW - Chronic lymphocytic leukemia
KW - Dose escalation
KW - Lenalidomide
KW - Phase 1
KW - Relapsed or refractory
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U2 - 10.3109/10428194.2011.618232
DO - 10.3109/10428194.2011.618232
M3 - Article
C2 - 21879809
AN - SCOPUS:84863115505
SN - 1042-8194
VL - 53
SP - 417
EP - 423
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
IS - 3
ER -