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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Correlative studies
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Relapse-free Survival (RFS)
Time from date of treatment start until the date of first objective documentation of disease-relapse.
Time frame: Up to 7 Years
Overall Survival (OS)
Time from date of treatment start until date of death due to any cause or last Follow-up. Survival will be measured by the estimated median survival computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative survival drops below 50%, if present. If not present then the median Overall Survival is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Time frame: Up to 7 Years
Event-free Survival (EFS)
Time from date of treatment start until the date of first objective documentation of disease-relapse, death or discontinuation due to adverse events.
Time frame: Up to 7 Years
Complete Response (CR) Duration
Complete Response is defined as disappearance of all clinical and/or radiologic evidence of disease, including extramedullary leukemia. Neutrophil count \>/= 1.0 x 10\^9/L and platelet count\>/= 100 x 10\^9, and bone marrow differential showing \</=5%blasts. Response date to loss of response or last follow up. Remission duration will be measured by the estimated median remission duration computed by Kaplan-Meier (K-M) analysis, which is the time point at which the cumulative remission duration drops below 50%, if present. If not present then median remission duration is not reached and not available (NA) as there are an insufficient number of participants with events. In either case ranges are provided for observed survival intervals used in the K-M analysis.
Time frame: Up to 7 years
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