title: A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia.
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.
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA. Electronic address: kami.maddocks@osumc.edu.
authors.forename: Kami
authors.initials: K
authors.lastname: Maddocks
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA.
authors.forename: Amy S
authors.initials: AS
authors.lastname: Ruppert
authors.affiliation: Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Rebekah
authors.initials: R
authors.lastname: Browning
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Jones
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Flynn
authors.affiliation: Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Kefauver
authors.affiliation: Division of Pharmaceutics, College of Pharmacy, USA.
authors.forename: Yue
authors.initials: Y
authors.lastname: Gao
authors.affiliation: Division of Pharmaceutics, College of Pharmacy, USA.
authors.forename: Yao
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Division of Pharmaceutics, College of Pharmacy, USA.
authors.forename: Darlene M
authors.initials: DM
authors.lastname: Rozewski
authors.affiliation: Division of Pharmaceutics, College of Pharmacy, USA.
authors.forename: Ming
authors.initials: M
authors.lastname: Poi
authors.affiliation: Comprehensive Cancer Center, The Ohio State University, USA; Division of Pharmaceutics, College of Pharmacy, USA.
authors.forename: Mitch A
authors.initials: MA
authors.lastname: Phelps
authors.affiliation: Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Erica
authors.initials: E
authors.lastname: Harper
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Amy J
authors.initials: AJ
authors.lastname: Johnson
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: John C
authors.initials: JC
authors.lastname: Byrd
authors.affiliation: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, USA.
authors.forename: Leslie A
authors.initials: LA
authors.lastname: Andritsos
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D013792:Thalidomide; D000077269:Lenalidomide
keywords: Chronic Lymphocytic Leukemia; Lenalidomide; Maintenance; Relapse; Tumor flare
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