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Lenalidomide in Treating Patients With High Risk Acute Myeloid Leukemia in Remission

Secondary Acute Myeloid Leukemia Clinical Trial

Official title:
Phase II Study of Lenalidomide Maintenance in Patients With High Risk AML in Remission

Clinical Trial Summary

This phase II trial studies how well lenalidomide works in treating patients with acute myeloid leukemia that have had a decrease in or disappearance of signs and symptoms of cancer, although cancer still may be in the body and may be likely to come back or spread. Biological therapies, such as lenalidomide, use substances made from living organisms that may kill cancer cells by blocking blood flow to the cancer and by stimulating white blood cells to kill the cancer cells.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) treated with lenalidomide maintenance therapy after achieving remission. SECONDARY OBJECTIVES: I. To assess overall survival (OS) of patients with AML treated with lenalidomide maintenance. II. To assess event-free survival (EFS) of patients with AML treated with lenalidomide maintenance. III. To assess the duration of remission (CRd) of patients with AML treated with lenalidomide maintenance. IV. To assess toxicity and safety of lenalidomide maintenance in patients with AML. V. To assess the effects of lenalidomide maintenance on natural killer (NK) cell modulation and dynamics of minimal residual disease and their relationship to outcomes. OUTLINE: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6-12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02126553
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date November 13, 2014
Completion date November 30, 2021
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