An Open-label Phase II Study of Lirilumab (BMS-986015) in Combination with 5-azacytidine (vidaza) for the Treatment of Patients with Refractory/Relapsed Acute Myeloid Leukemia
The goal of this clinical research study is to find the highest tolerated dose of the combination of lirilumab and 5-azacytidine that can be given to patients with AML or high-risk MDS. Researchers also want to learn if the drug combination can help to control the disease. The safety of the drug combination will also be studied.
Treatment Location: N/A
Primary Objectives Part a. Lead-in phase: 1. To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of lirilumab in combination with 5-azacytidine in patients with refractory/ relapsed acute myeloid leukemia (AML). Part b. Phase II: 1. To determine the overall response rate (ORR) of lirilumab in combination with 5-azacytidine in patients with refractory/ relapsed AML. Secondary Objectives: 1. To determine the duration of response, disease-free survival (DFS), and overall survival (OS) of patients with refractory/ relapsed AML treated with this combination. 2. To determine the safety of lirilumab in combination with 5-azacytidine in patients with refractory/ relapsed AML. Exploratory Objectives: 1. To study immunological and molecular changes in the peripheral blood and bone marrow in response to lirilumab and 5-azacytidine therapy. 2. To determine induction of hypomethylation and DNA damage during therapy with this combination and its correlation with response.
IRB Review and Approval Date: 04/20/2015
Recruitment Status: Closed
Projected Accrual: N/A
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