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Ivosidenib is an oral inhibitor of the mutant isochlic acid dehydrogenase 1 (IDH1) and has been approved for the treatment of IDH1 mutant (mIDH1) acute myeloid leukemia (AML).
previous studies have shown that adding azatide to ivetinist enhances mIDH1 inhibition-related differentiation and apoptosis.
The study is an open-label, multi-center Phase IB trial designed to assess the efficacy and safety of iverine (500 mg, 1/day, oral) in combination with azatide (75 mg/m2, 28 days of treatment, subdernation injection) for newly diagnosed mIDH1 AML patients who are not suitable for intensive induction chemotherapy.
23 patients were treated with Yvonne combined aza cytosine (middle age 76).
treatment-related adverse reactions occurring in more than 10% of patients≥ level 3 adverse reactions were a reduction in neutral granulocytes (22%), anemia (13%), plate plate plate reduction (13%) and an extension of the electrostome QT period (13%).
adverse reactions of particular concern include IDH differentiation syndrome (17%), electroencephalogram QT interstitial extension (26%) at all levels, and level ≥3 leuemia (9%).
15.1 months of remission and changes in IDH1 mutation status during treatment, and as of February 19, 2019, 10 patients continued treatment.
overall mitigation rate was 78.3 per cent (18/23) and the overall mitigation rate was 60.9 per cent (14/23).
follow-up for 16 months, and the medium remission duration of the remission patients did not reach.
12-month survival rate is estimated at 82.0 per cent.
mIDH1 was removed from the bone marrow monocytes in 10 (71.4%) of the 14 patients who received complete remission.
the correlation between mutations and clinical prognostics, ivetinist is well- resistant and expected to be safely consistent with the monotherapy of each drug.
is thorough and long-lasting, and most patients with complete remission can achieve mIDH1 mutation removal.