Phase 1 Study of JNJ-90189892 Alone or with Azacitadine and Venetoclax for Adults with Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Neoplasms

What this Trial Is About

Researchers are evaluating the drug JNJ-90189892 for adults with relapsed or refractory acute myeloid leukemia AML or high-risk myelodysplastic neoplasms MDS, which are types of blood and bone marrow cancers that do not respond to treatment or return after treatment. The study aims to find safe and effective doses of JNJ-90189892 alone and in combination with azacitadine AZA and venetoclax VEN for these conditions. This is a Phase 1 trial focused on treatment safety, tolerability, and dosing regimens across different patient groups. The study has multiple parts Part 1 involves gradually increasing doses of JNJ-90189892 to identify the recommended Phase 2 dose RP2D. Part 2 expands the study with this dose to further assess safety and effectiveness. Part 3 tests JNJ-90189892 combined with AZA and VEN in participants with relapsed or refractory AML to find a recommended combination dose. Part 4 includes newly diagnosed AML patients receiving the drug combination starting at the safe dose from Part 3. Doses are carefully adjusted based on decisions by the study evaluation team. Participants will be closely monitored from screening through treatment and up to 30 days after the last dose, totaling about 2.5 years. Assessments include tracking adverse events, laboratory tests, and measuring drug levels in the blood. The study also evaluates treatment responses, transfusion independence, and overall survival in certain groups. Researchers will continuously check safety and effectiveness throughout the study period to understand how the drug and combinations perform in these patients.

A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms