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 ]

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.


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 ]

Type and intensity of adverse events related with lenalidomide


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