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

被引：50

作者：

Wendtner, Clemens-Martin ^{[1
]}

Hillmen, Peter ^{[2
]}

Mahadevan, Daruka ^{[3
]}

Buehler, Andreas ^{[4
]}

Uharek, Lutz ^{[5
]}

Coutre, Steven ^{[6
]}

Frankfurt, Olga ^{[7
]}

Bloor, Adrian ^{[8
]}

Bosch, Francesc ^{[9
]}

Furman, Richard R. ^{[10
]}

Kimby, Eva ^{[11
]}

Gribben, John G. ^{[12
]}

Gobbi, Marco ^{[13
]}

Dreisbach, Luke ^{[14
]}

Hurd, David D. ^{[15
]}

Sekeres, Mikkael A. ^{[16
]}

Ferrajoli, Alessandra ^{[17
]}

Shah, Sheetal

Zhang, Jennie ^{[18
]}

Moutouh-de Parseval, Laure ^{[18
]}

Hallek, Michael ^{[1
]}

Heerema, Nyla A. ^{[19
]}

Stilgenbauer, Stephan ^{[4
]}

Chanan-Khan, Asher A. ^{[20
]}

机构：

[1] Univ Cologne, Dept Internal Med 1, CIO, D-50937 Cologne, Germany

[2] St James Univ Hosp, Dept Haematol, Leeds, W Yorkshire, England

[3] Univ Arizona, Arizona Canc Ctr, Tucson, AZ USA

[4] Univ Ulm, Ulm, Germany

[5] Charite, Med Clin 3, D-13353 Berlin, Germany

[6] Stanford Univ, Sch Med, Stanford, CA 94305 USA

[7] Northwestern Univ, Robert H Lurie CCC, Chicago, IL 60611 USA

[8] Christie NHS Fdn Trust, Manchester, Lancs, England

[9] Univ Hosp Vall dHebron, Barcelona, Spain

[10] Cornell Univ, Weill Med Coll, New York, NY 10021 USA

[11] Karolinska Univ Hosp, Stockholm, Sweden

[12] Queen Mary Univ London, Ctr Haematooncol, Barts Canc Inst, Barts & London Sch Med & Dent, London, England

[13] Univ Genoa, Chair Hematol, Genoa, Italy

[14] Desert Hematol Oncol Med Grp Inc, Banning, CA USA

[15] Wake Forest Univ, Winston Salem, NC 27109 USA

[16] Cleveland Clin Taussig Canc Inst, Cleveland, OH USA

[17] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, Houston, TX 77030 USA

[18] Celgene Corp, Summit, NJ USA

[19] Ohio State Univ, Dept Pathol, Columbus, OH 43210 USA

[20] Roswell Pk Canc Inst, Buffalo, NY 14263 USA

来源：

LEUKEMIA & LYMPHOMA | 2012年 / 53卷 / 03期

关键词：

Chronic lymphocytic leukemia; lenalidomide; phase; 1; dose escalation; relapsed or refractory; TUMOR LYSIS SYNDROME; CLINICAL-EFFICACY; T-CELLS; RITUXIMAB; THERAPY;

D O I：

10.3109/10428194.2011.618232

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：417 / 423

页数：7

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