a study of bomedemstat (img-7289/mk-3543) with and without atra, in participants with advanced myeloid malignancies (img-7289-ctp-101/mk-3543-001)

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this is an open label study of the dose and duration of an orally administered lysine-specific demethylase 1 (lsd1) inhibitor, bomedemstat, in patients with high-risk acute myeloid leukemia (aml) and high-risk myelodysplastic syndrome (mds). some participants may also receive all-trans retinoic acid (atra; also known as tretinoin and vesanoid®) in combination with bomedemstat. this study investigates the following: * the safety and tolerability of bomedemstat with and without atra * the pharmacodynamic effect of different doses of bomedemstat and treatment durations, as well as bomedemstat administered in combination with atra * the pharmacokinetics of bomedemstat with and without atra


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: high-risk acute myeloid leukemia (aml) * have a diagnosis of aml according to the world health organization (who) criteria * have an eastern cooperative oncology group (ecog) performance status score ≤2 * have aml that is classified as high risk as defined by one of the following: ≥ 60 years of age who were not candidates for or have refused standard chemotherapy; ≥18 years of age with de novo or secondary aml who were not expected to benefit from standard remission-induction chemotherapy; or had relapsed/refractory aml after no more than 3 previous lines of chemotherapy. high-risk myelodysplastic syndromes (mds) * have a diagnosis of myelodysplastic syndromes according to the world health organization (who) criteria * have either an international prognostic scoring system (ipss) score equivalent to intermediate-2 risk or higher, or a revised international prognostic scoring system (ipss-r) score equivalent to intermediate risk or higher. * have mds that is classified as high risk as defined by one of the following: participants who have failed first-line therapy; or treatment-related mds, except if it is associated with favorable cytogenetics, and not a candidate for stem cell transplantation * prior autologous stem cell transplant is allowed if a minimum of 3 months has elapsed from the time of transplant and the patient has recovered from transplant-associated toxicities * prior allogeneic stem cell transplant is allowed, provided all of the following criteria are met: transplant was \>120 days prior to study enrollment; no immunosuppressive medications have been taken for at least 1 month; and no active graft versus host disease (gvhd), excluding grade 1 skin gvhd * has a life expectancy \>12 weeks exclusion criteria: * is receiving other treatments for the condition (with exceptions and time limits) * has had major surgery in last 4 weeks or minor surgery in the last 2 weeks * has a scheduled hematopoietic stem-cell transplant * is currently using prohibited medications * has clinical evidence of central nervous system (cns) or pulmonary leukostasis, disseminated intravascular coagulation, or cns leukemia * has a concurrent second active and non-stable malignancy * has an uncontrolled active infection * has known human immunodeficiency virus (hiv) infection or active hepatitis b or hepatitis c virus infection * has used an investigational agent within last 14 days * is a pregnant or lactating females

Keywords: lsd1 high-risk acute myeloid leukemia high-risk myelodysplastic syndrome