作者
William Blum, Rebecca B Klisovic, Heiko Becker, Xiaoxia Yang, Darlene M Rozewski, Mitch A Phelps, Ramiro Garzon, Alison Walker, Jason C Chandler, Susan P Whitman, John Curfman, Shujun Liu, Larry Schaaf, Jon Mickle, Cheryl Kefauver, Steven M Devine, Michael R Grever, Guido Marcucci, and, John C Byrd
发表日期
2010/11/20
期刊
Journal of clinical oncology
卷号
28
期号
33
页码范围
4919-4925
出版商
American Society of Clinical Oncology
简介
Purpose
Lenalidomide is effective in myeloma and low-risk myelodysplastic syndromes with deletion 5q. We report results of a phase I dose-escalation trial of lenalidomide in relapsed or refractory acute leukemia.
Patients and Methods
Thirty-one adults with acute myeloid leukemia (AML) and four adults with acute lymphoblastic leukemia (ALL) were enrolled. Lenalidomide was given orally at escalating doses of 25 to 75 mg daily on days 1 through 21 of 28-day cycles to determine the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD), as well as to provide pharmacokinetic and preliminary efficacy data.
Results
Patients had a median age of 63 years (range, 22 to 79 years) and a median of two prior therapies (range, one to four therapies). The DLT was fatigue; 50 mg/d was the MTD. Infectious complications were frequent. Plasma lenalidomide concentration increased proportionally with dose. In AML …
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W Blum, RB Klisovic, H Becker, X Yang, DM Rozewski… - Journal of clinical oncology, 2010