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Precision Medicine for Chronic Myelomonocytic Leukaemia in Adults: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling.
Other Non-Commercial Sponsor
South Australian Health & Medical Research Institute Ltd
This is a non-randomised, open trial investigating precision medicine for adults with Chronic Myelomonocytic Leukaemia (CMML). As part of the screening process, participants will be required to have a bone marrow aspirate and trephine to test for certain acquired mutations that can be present in CMML. The study is looking for participants with TET2 and/or RAS pathway mutations.
Participants with TET2 mutations will receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on days 1-5, 8-9 or days 1-7 for a total of 7 doses per 28-day cycle) in combination with sodium ascorbate (administered intravenously at a dose of 30g on days 1-5, 8-9 or days 1-7 [15g for 1st dose only, 30g thereafter if no evidence of tumour lysis syndrome]). Participants in this cohort will also self-administered sodium ascorbate (orally at a dose of 1.1g) at home on days where intravenous sodium ascorbate is not scheduled.
Participants with RAS pathway mutations or both TET2 and RAS mutations, will receive azacitidine (administered subcutaneously at a dose of 75mg/m2 on days 1-5, 8-9 or days 1-7 for a total of 7 doses per 28-day cycle) in combination with lenzilumab (administered intravenously at a dose of 552mg on days 1 & 15 of Cycle 1. Day 1 only for all subsequent cycles).