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

Official record

Identifier

NCT06419634

Recruiting locations

countries

United StatesCanadaSpain

Interventions studied

BMS-986497AzacitidineVenetoclax

Lead sponsor

Bristol-Myers Squibb

Target enrolment

34 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Terminated

First posted

May 17, 2024

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Leukemia