The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission. At the same time, the study evaluate the security of lenalidomide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Initial dose of oral lenalidomide is 10 mg/day for 28 days every 28 days, during 6 months. In case of response on day 169, patient will follow a treatment extension phase. The dose of lenalidomide should be the same as the last dose for initial phase, until 24 months or progression disease
Hospital Clínico y Provincial de Barcelona
Barcelona, Barcelona, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Madrid, Spain
Hospital Juan Canalejo.
A Coruña, Spain
Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy
Evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained reponse treatment (total resistance) or partial remission.
Time frame: 12 months
Safety and tolerability: Type and intensity of adverse events related with lenalidomide
Type and intensity of adverse events related with lenalidomide
Time frame: 1 year
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Hospital General de Alicante.
Alicante, Spain
Hospital Germans Trias I Pujol
Badalona, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Ramón y Cajal. Madrid
Madrid, Spain
H. Carlos Haya
Málaga, Spain
Hospital Central de Asturias.
Oviedo, Spain
Hospital Clínico Universitario de Salamanca.
Salamanca, Spain
...and 2 more locations