RECRUITING

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

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Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromeBMS-986497First-in-HumanORM-6151Acute myeloid leukemia (AML)Myelodysplastic syndrome (MDS)Cluster of differentiation 33 (CD33)G1 to S phase transition 1 (GSPT1)Open label study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-05-29
Study Completion:2030-09-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06419634

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  2. * Detectable levels of cluster of differentiation 33 (CD33) expression.
  3. * Failed alternative therapies with established benefit.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.
  1. * Acute Promyelocytic Leukemia.
  2. * Clinically active central nervous system leukemia.
  3. * Active malignant solid tumor.
  4. * Pregnant or breastfeeding.
  5. * Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Yale-New Haven Hospital
New Haven, Connecticut, 06510
United States
Local Institution - 0010
Chicago, Illinois, 60611
United States
Local Institution - 0007
Boston, Massachusetts, 02114
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University School of Medicine, Siteman Cancer Center
Saint Louis, Missouri, 63108
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Local Institution - 0009
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29
Study Completion Date2030-09-16

Study Record Updates

Study Start Date2024-05-29
Study Completion Date2030-09-16

Terms related to this study

Keywords Provided by Researchers

  • BMS-986497
  • First-in-Human
  • ORM-6151
  • Acute myeloid leukemia (AML)
  • Myelodysplastic syndrome (MDS)
  • Cluster of differentiation 33 (CD33)
  • G1 to S phase transition 1 (GSPT1)
  • Open label study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome