Clinical Trial: LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: PILOT STUDY PHASE II, Multicenter, Non-randomized, TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN INDUCTION AND POST-INDUCTION IN PATIENTS WITH NOVO Acute Myeloid Leukemia (AML) WITH Cytogenetic
Brief Summary:
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.
Detailed Summary:
Sponsor: PETHEMA Foundation
Current Primary Outcome: Effectivity: Duration of response with lenalidomide after conventional induction chemotherapy [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety and tolerability: Type and intensity of adverse events related with lenalidomide [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: PETHEMA Foundation
Dates:
Date Received: July 29, 2010
Date Started: January 2011
Date Completion:
Last Updated: April 4, 2014
Last Verified: April 2014