Study of BMS-986497 (ORM-6151) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Launched by BRISTOL-MYERS SQUIBB · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called BMS-986497, which is being tested on patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The main goals of the study are to determine how safe the drug is, how well it works, and what the right dose should be for patients. The trial is currently recruiting participants who are adults aged 65 and older, and who have specific types of AML or MDS that have not responded to other treatments.

To be eligible for this trial, participants must have certain detectable markers in their cancer cells and should have already tried other therapies that did not work. They also need to have good overall health, as determined by a simple performance scale. However, people with certain conditions, such as acute promyelocytic leukemia or active brain leukemia, as well as pregnant or breastfeeding women, cannot participate. If someone decides to join the trial, they can expect close monitoring by the research team to ensure their safety and to track how well the new drug is working for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
• • Detectable levels of cluster of differentiation 33 (CD33) expression.
• • Failed alternative therapies with established benefit.
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
• Exclusion Criteria:
• • Acute Promyelocytic Leukemia.
• • Clinically active central nervous system leukemia.
• • Active malignant solid tumor.
• • Pregnant or breastfeeding.
• • Other protocol-defined inclusion/exclusion criteria apply.

Trial Officials