John Mascarenhas
This is a phase II, multicenter, open-label study evaluating the feasibility, safety, and efficacy of oral tetrahydrouridine-decitabine (THU-decitabine) in patients with advanced myeloproliferative neoplasms (MPN).
This is a phase 2, multicenter trial evaluating the feasibility of administering oral THU-Dec with or without JAK2 inhibitor in patients with advanced MPNs. Eligible subjects will receive oral THU-Dec orally once weekly on a four week (28 day) cycle for a core study period of 6 cycles (24 weeks). The primary endpoint will be assessed after 6 cycles of treatment. Feasibility will be assessed as the treatment completion rate, defined as the proportion of patients who receive ≥75% of planned THU-Decitabine doses for at least 6 cycles or who discontinue treatment to receive allogeneic hematopoieti…
Inclusion Criteria: * Adults ≥ 18 years of age * Diagnosis of one of the following: * Accelerated-phase (≥ 10% blasts in PB or BM) or blast-phase (≥ 20% blasts in PB or BM) myeloproliferative neoplasm with a history of prior myelofibrosis, polycythemia vera, or essential thrombocythemia; or * Chronic phase myelofibrosis with 4-9% circulating blasts * Eastern Cooperative Oncology Group (ECOG) 0-2 * Concurrent use of physician's choice JAK1/2 inhibitors is permitted. Patients must be on stable dose of JAK2i for at least 4 weeks prior to starting the clinical trial. * Body weight ≥ 41 kg * Abili…
Combination of Tetrahydrouridine and Decitabine oral treatment. Treatment is ingested weekly without interruption. For convenience of communication and planning, 4 weeks of treatment (28 days) is considered a treatment cycle. The first 2 cycles of therapy (week 1-8 of therapy) is considered an induction phase. After the induction phase (Cycle 3+): Treatment continues weekly.
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