Refractory Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase Ib/II Study of the Histone Methyltransferase Inhibitor Pinometostat in Combination With Azacitidine in Patients With 11q23-Rearranged Acute Myeloid Leukemia
This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To determine if the combination of pinometostat, at a dose of 54 or 90 mg/m^2/day, and azacitidine, at a dose of 75 mg/m^2 daily for 7 days, is safe and tolerable in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/ refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase Ib) II. To determine the preliminary efficacy, as determined by overall response rate (complete response [CR], complete response with incomplete bone marrow recovery [CRi], partial response [PR], and morphologic leukemia-free state [MLFS]), of pinometostat administered at the maximum tolerated dose from the phase 1b, combined with azacitidine administered at 75 mg/m^2 daily for 7 days, in patients with MLL-rearranged acute myeloid leukemia, either in the relapsed/refractory setting or in those who choose not to undergo standard induction therapy in the previously untreated setting. (Phase II) SECONDARY OBJECTIVES: I. Perform correlative studies to evaluate for on-target effects, cellular differentiation, and decreased leukemia cell proliferation in these patients. (Phase Ib and II) II. To observe and record anti-tumor activity. (Phase Ib) OUTLINE: This is a phase Ib, dose-escalation study of pinometostat followed by a phase II study. Patients receive pinometostat intravenously (IV) continuously on days 1-28 and azacitidine IV over 10-40 minutes or subcutaneously (SC) for 7 of the first 10 days of the cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 month. ;
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