This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting
Phase 3

Luspatercept

Sponsor:

Bristol-Myers Squibb

Code:

NCT06045689

Conditions

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Luspatercept

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

Conditions

Myelodysplastic Syndromes

Study ID

NCT06045689

Start date

Oct 5, 2023

Status verified date

Mar, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  • Participant must have red blood cell transfusions according to study criteria.

Exclusion Criteria:

  • Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
  • Participant has had a prior allogeneic or autologous stem cell transplant.
  • Participant has known history or diagnosis of AML.
  • Participant has uncontrolled hypertension.

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: erythropoiesis-stimulating agents (ESA) naïve

experimental: Cohort 2: ESA relapsed or refractory

Interventions

Luspatercept

Specified dose on specified days.

Primary outcome measure

  • Number of participants who achieve red blood cell transfusion independence (RBC-TI) for 8 weeks with a simultaneous mean hemoglobin (Hb) increase of ≥ 1 g/dL from Week 1 to Week 24 [ Time Frame: Up to week 24 ]

Central Contacts and Locations

Central contacts

BMS Study Connect www.BMSStudyconnect.com

855-907-3286Clincal.Trials@bms.com

Locations

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720-3379

Contacts

Vu Phan, Site 0051

562-735-0602

Smilow Cancer Hospital at Yale New Haven

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Amer Zeidan, Site 0033

203-737-7078

Florida Cancer Specialists - NORTH - SCRI - PPDS

Recruiting

Saint Petersburg, Florida, United States, 33705

Contacts

Adewale Fawole, Site 0055

727-216-1143

Florida Cancer Specialists - SOUTH - SCRI - PPDS

Recruiting

Wellington, Florida, United States, 33414

Contacts

Ivor Percent, Site 0056

239-274-9930

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160-8500

Contacts

Jesus Gonzalez Lugo, Site 0020

913-945-6674

Mercy Health - Paducah Medical Oncology and Hematology

Recruiting

Paducah, Kentucky, United States, 42003-7915

Contacts

Wederson Claudino, Site 0025

000-000-0000

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Ahmad Mattour, Site 0011

313-433-1718

Washington University School of Medicine

Recruiting

Saint Louis, Missouri, United States, 63110

Atlantic Hematology Oncology

Recruiting

Morristown, New Jersey, United States, 07960-6136

Contacts

Mohamad Cherry, Site 0058

973-971-7906

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Lewis Silverman, Site 0032

212-241-5520

Oncology Associates of Oregon, P.C.

Recruiting

Eugene, Oregon, United States, 97401-6043

Contacts

Luke Fletcher, Site 0054

541-683-5001

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Texas Oncology - Amarillo

Recruiting

Amarillo, Texas, United States, 79106-1781

Contacts

Praveen Kumar Tumula, Site 0043

806-358-8654

Wheeling Hospital Schiffler Cancer Center

Recruiting

Wheeling, West Virginia, United States, 26003-6379

Contacts

Bhavana Bhatnagar, Site 0031

614-293-7961

Froedtert and The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Ravi Narra, Site 0003

414-805-4600

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Keywords

  • Luspatercept
  • Transfusion dependent
  • ACE-536
  • Anemia
  • Blood Transfusion
  • Red Blood Cell Transfusion
  • Myelodysplastic Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2025-04-02.