A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia

Leuk Res. 2014 Sep;38(9):1025-9. doi: 10.1016/j.leukres.2014.05.011. Epub 2014 May 29.

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.

Publication types

  • Clinical Trial, Phase I
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Feasibility Studies
  • Female
  • Humans
  • Lenalidomide
  • Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
  • Leukemia, Lymphocytic, Chronic, B-Cell / pathology
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Recurrence
  • Thalidomide / administration & dosage
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives*
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Thalidomide
  • Lenalidomide

Associated data

  • ClinicalTrials.gov/NCT00466895