Spots Global Cancer Trial Database for Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

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Trial Identification

Brief Title: Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

Official Title: Sequential Treatment With Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia

Study ID: NCT01743859

Conditions

Acute Myeloid Leukemia

Interventions

Azacitidine

Lenalidomide

Off Therapy

Study Description

Brief Summary: The primary objective of this study is to determine the complete remission/complete remission with incomplete recovery of blood counts (CR/CRi) rate for relapsed and refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients.

Detailed Description: AML patients with relapsed and refractory disease have very poor outcomes. Sequential azacitidine and lenalidomide was recently shown by the PI of this study to be well-tolerated and effective in elderly, treatment naïve AML patients. Observations from this study and others that have piloted this combination have suggested that patients who received and failed prior treatments may also respond to this regimen. Therefore, the sequential combination of azacitidine with lenalidomide could potentially improve outcomes for relapsed and refractory AML patients by providing them with a treatment option that is tolerable and potentially clinically synergistic. To determine the efficacy of this combination in this population, we will pilot this phase 2 study.