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A Phase I Study of Duvelisib in Combination with CC-486 in Lymphoid Malignancy
The purpose of the study is to find a safe dose and to evaluate the safety and tolerability of the drug CC-486, in combination with duvelisib.
1. To evaluate the safety and dose limiting toxicity of the combination of PI3K inhibitor (Duvelisib) with hypomethylating agent (CC-486) in patients with lymphoid malignancy; 2. To evaluate the overall response rate to the treatment with combination therapy; 3. To evaluate the disease control rate of the combination; 4. To evaluate the progression free survival and overall survival in patients treated with the combination therapy. Exploratory Objectives: 1. To evaluate the changes in different T cells subpopulation in response to PI3K inhibition and hypomethylation 2. To evaluate the changes in pAKT in response to single agent Duvelisib in comparison to combination Duvelisib and CC-486
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