Study of BMS-986497 (ORM-6151) in Participants 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).

Conditions

Acute Myeloid Leukemia, Myelodysplastic Syndrome

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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

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

Condition
Acute Myeloid Leukemia
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale-New Haven Hospital, New Haven, Connecticut, United States, 06510

Chicago

Local Institution - 0010, Chicago, Illinois, United States, 60611

Boston

Local Institution - 0007, Boston, Massachusetts, United States, 02114

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States, 63108

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Houston

University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

Local Institution - 0009, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Acute Promyelocytic Leukemia.
  • * Clinically active central nervous system leukemia.
  • * Active malignant solid tumor.
  • * Pregnant or breastfeeding.
  • * Other protocol-defined inclusion/exclusion criteria apply.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2030-09-16