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TERMINATED
NCT06419634
PHASE1

Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Official title: Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2024-05-29

Completion Date

2026-08-28

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

BMS-986497

Specified dose on specified days

DRUG

Azacitidine

Specified dose on specified days

DRUG

Venetoclax

Specified dose on specified days

Locations (10)

Local Institution - 0011

New Haven, Connecticut, United States

Local Institution - 0010

Chicago, Illinois, United States

Local Institution - 0014

Boston, Massachusetts, United States

Local Institution - 0013

St Louis, Missouri, United States

Local Institution - 0008

Hackensack, New Jersey, United States

Local Institution - 0006

Houston, Texas, United States

Local Institution - 0002

Toronto, Ontario, Canada

Local Institution - 0003

Montreal, Quebec, Canada

Local Institution - 0020

Barcelona, Catalunya [Cataluña], Spain

Local Institution - 0023

Seville, Spain