A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia
Kami Maddocks, Amy S Ruppert, Rebekah Browning, Jeffrey Jones, Joseph Flynn, Cheryl Kefauver, Yue Gao, Yao Jiang, Darlene M Rozewski, Ming Poi, Mitch A Phelps, Erica Harper, Amy J Johnson, John C Byrd, Leslie A Andritsos, Kami Maddocks, Amy S Ruppert, Rebekah Browning, Jeffrey Jones, Joseph Flynn, Cheryl Kefauver, Yue Gao, Yao Jiang, Darlene M Rozewski, Ming Poi, Mitch A Phelps, Erica Harper, Amy J Johnson, John C Byrd, Leslie A Andritsos
Abstract
Adequate dosing of lenalidomide in Chronic Lymphocytic Leukemia (CLL) remains unclear. This study determined maximum tolerated dose (MTD) in relapsed CLL patients (Cohort A) and patients achieving a partial response (PR) or better to recent therapy (Cohort B). Thirty-seven patients were enrolled. MTD was 2.5mg followed by 5.0mg continuous. In Cohort A, tumor flare grade 1-2 occurred in 15 patients (50%) and grade 3 in 1 patient (3%). Cohort A had 19 of 23 evaluable (83%) patients, 4 PR (17%) and 15 (65%) stable disease (SD), Cohort B had 6 of 7 patients (86%) with SD. Despite overall response rate not being high, many patients remained on therapy several months with SD.
Trial registration: ClinicalTrials.gov NCT00466895.
Keywords: Chronic Lymphocytic Leukemia; Lenalidomide; Maintenance; Relapse; Tumor flare.
Conflict of interest statement
Conflict of interest statement
None declared.
Copyright © 2014 Elsevier Ltd. All rights reserved.
Source: PubMed