Health Trials

Iadademstat in Combination With Azacitidine and Venetoclax in Treating Newly Diagnosed Acute Myeloid Leukemia

ConditionsAcute Myeloid LeukemiaMyelodysplastic Syndrome/Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

This phase I trial tests the safety, side effects, and best dose of iadademstat when given together with azacitidine and venetoclax in treating patients with newly diagnosed acute myeloid leukemia (AML). Iadademstat inhibits the LSD1 protein and may lead to inhibition of cell growth in LSD1-overexpressing cancer cells. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving iadademstat with azacitidine and venetoclax may be safe, tolerable and/or effective in treating patients with newly diagnosed AML who cannot undergo intensive chemotherapy.

Eligibility criteria

Qualifiers

Patients at least 18 years of age will be considered for inclusion without bias against gender identity, race, or ethnicity

Ability to comprehend the investigational nature of the study and provide written informed consent

Documented intermediate- or adverse-risk AML based on European Leukemia Network (ELN) 2022 criteria

Note: Cases of AML (MDS) overlap with 10-19% bone marrow (BM) or peripheral blood (PB) blasts will be considered

Disqualifiers

Prior allergic response to iadademstat (IADA), venetoclax, azacitidine, or any excipients in the formulations

Body weight < 50 kg

Investigational therapy within 5 half-lives or, if unknown, within 28 days prior to start of IADA

Treatment for AML within 14 days prior to start of IADA. Cytoreduction for patients with proliferative disease must meet the criteria listed in inclusion criteria

Trial design

Treatments tested in this trial

  • Azacitidine
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Echocardiography Test
  • Iadademstat
  • Multigated Acquisition Scan
  • Questionnaire Administration
  • Venetoclax

Treatment groups

30 Participants
are divided into 4 treatment groups

Sponsors and collaborators

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Oryzon Genomics S.A.

Collaborator

Source ClinicalTrials.gov