The aim of this study is to investigate the efficacy of lenalidomide in high risk MDS or AML with chromosome 5 aberrations.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Initial dose is oral lenalidomide 10 mg daily continuously. The dose should be increased to 20 mg day 1 in week 6 and to 30 mg day 1 in week 10. This dose should be kept for seven weeks. Thus, the total study period is 16 weeks.
Department of Hematology, Aalborg Hospital
Aalborg, Denmark
Department of Hematology, Aarhus University Hospital
Aarhus, Denmark
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
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
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