LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT01198054|
Recruitment Status : Terminated
First Posted : September 9, 2010
Last Update Posted : April 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Lenalidomide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Abnormality Monosomy 5|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5)
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198054
|Hospital General de Alicante.|
|Hospital Germans Trias I Pujol|
|Hospital Clínico y Provincial de Barcelona|
|Hospital Juan Canalejo.|
|La Coruña, Spain|
|Hospital 12 de Octubre|
|Hospital Clínico San Carlos de Madrid|
|Hospital Ramón y Cajal. Madrid|
|H. Carlos Haya|
|Hospital Central de Asturias.|
|Hospital Clínico Universitario de Salamanca.|
|Hospital Universitario Virgen del Rocío.|
|Hospital La Fe de Valencia|
|Principal Investigator:||Sanz Miguel, Dr||PETHEMA Foundation|