Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT06419634 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG BMS-986497

Study Locations (15)

Massachusetts

  • Local Institution - 0007 — Boston
  • Massachusetts General Hospital — Boston

Other

  • Local Institution - 0018 — Paris
  • Local Institution - 0022 — Toulouse

Connecticut

  • Yale-New Haven Hospital — New Haven

Illinois

  • Northwestern Memorial Hospital — Chicago

Missouri

  • Washington University School of Medicine, Siteman Cancer Center — St Louis

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack

New York

  • Columbia University Irving Medical Center — New York

Texas

  • University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2024-05-29
Est. Completion 2030-09-16
Phase Phase 1

Sponsor

Bristol-Myers Squibb

504 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06419634

The ClinicalTrials.gov registry entry for NCT06419634 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Venetoclax is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06419634 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, Other, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06419634 about?

NCT06419634 is a clinical study titled "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". 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 ...

What is the current status of trial NCT06419634?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2024-05-29. Estimated completion is 2030-09-16.

What conditions does trial NCT06419634 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06419634?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), BMS-986497 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06419634?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06419634 being conducted?

This trial has 15 study locations across Connecticut, Illinois, Massachusetts, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial