Clinical Trial: Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicentre Phase II Study of the Efficacy and Safety of Lenalidomide in High-risk Myeloid Disease (High-risk MDS and AML) With a Karyotype Including Del(5q) or Monosomy

Brief Summary: The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.

Detailed Summary: Previous studies have shown that the immunomodulatory drug lenalidomide is effective in the treatment of low risk MDS with del(5q). Treatment of this subgroup of MDS patients resulted in 67% major erythroid responses and 45% complete cytogenetic responses. We therefore intend to test the efficacy of lenalidomide in a group of high-risk patients who are ineligible for conventional chemotherapy and who have a dismal prognosis. The patients must have a karyotype including del(5q) but patients with a karyotype including monosomy 5 are also eligible. We hypothesize that hight risk MDS or AML patients with other chromosomal aberrations than del(5q) can be affected by the lenalidomide effect.
Sponsor: Nordic MDS Group

Current Primary Outcome: Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe) after 16 weeks of lenalidomide treatment [ Time Frame: 16 weeks ]

Original Primary Outcome: Major cytogenetic response (50% or more reduction of the del5(q) or monosomy 5 FISH positive clone in the bone marrow using the LSI EGR1/D5S23,D5S721 FISH probe, see section 8.3) after 16 weeks of lenalidomide treatment [ Time Frame: 16 weeks ]

Current Secondary Outcome:

  • Minor and complete cytogenetic (FISH) response after 8 and 16 weeks [ Time Frame: 16 weeks ]
  • Red blood cell transfusion independence [ Time Frame: 16 weeks ]
  • Erythroid response [ Time Frame: 16 weeks ]
  • Bone marrow response (morphology) [ Time Frame: 16 weeks ]
  • Modification of gene expression profiling during treatment [ Time Frame: 16 weeks ]
  • Safety [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Nordic MDS Group

Dates:
Date Received: September 26, 2008
Date Started: October 2007
Date Completion:
Last Updated: April 26, 2012
Last Verified: January 2010