Go back to trials list
Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Description
The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Trial Eligibility
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.
Study Info
Organization
Bristol-Myers Squibb
Primary Outcome
Incidence of dose-limiting toxicities (DLTs)
Interventions
Locations Recruiting
Yale-New Haven Hospital
United States, Connecticut, New Haven
Local Institution - 0010
United States, Illinois, Chicago
Local Institution - 0007
United States, Massachusetts, Boston
Local Institution - 0014
United States, Massachusetts, Boston
Local Institution - 0013
United States, Missouri, Saint Louis
Interested in joining this trial?
Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.
![newsletter icon](https://static.healthtree.org/icons/newsletter-icon.png)
Get the latest thought leadership on your Acute Myeloid Leukemia delivered straight to your inbox
Subscribe to the weekly newsletter for news, stories, clinical trial updates, and helpful resources and events with cancer experts.
Thanks to our HealthTree Community for Acute Myeloid Leukemia Sponsors:
![Abbvie](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2Fabbvie%20bigger_c5e4f4af-fb3c-45ca-b9f0-831fb4c5f968.jpeg?alt=media)
![Astellas Pharma](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/university%2Fpublic%2Fshared%2Fastellas%20fo%20realz-100_8fd8c5cb-3421-4cfd-8aa6-07a70f67acf7.jpg?alt=media)
![Servier](https://firebasestorage.googleapis.com/v0/b/healthtree-production.appspot.com/o/gallery%2Fpublic%2Fservier_6f4f6f05-7255-45f8-8f3d-a07651617cbe.png?alt=media)