Luspatercept

Generic Name: Luspatercept

Brand Names: Reblozyl

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1373715-00-4

Unique Ingredient Identifier: AQK7UBA1LS

Background: Luspatercept is a recombinant fusion protein comprised of a modified extracellular domain of activin receptor type IIB fused to the FC domain of human IgG1. It was first approved for use in the United States in November 2019 under the brand name Reblozyl® for the treatment of anemia in patients with beta thalassemia who require regular blood transfusions. Lu...

Indication: Luspatercept is indicated for the treatment of:

Associated Conditions: Anemia

Associated Therapies: -

Clinical Trials

Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts

Phase 2

Terminated

Conditions: Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified
Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Biological: Luspatercept
Drug: Hydroxyurea
Other: Questionnaire Administration

First Posted Date: 2021-08-13

Last Posted Date: 2024-02-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 3

Registration Number: NCT05005182

Locations: 🇺🇸
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients

Phase 1

Recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Lenalidomide
Drug: Luspatercept

First Posted Date: 2020-09-04

Last Posted Date: 2024-08-22

Lead Sponsor: Mikkael Sekeres, MD

Target Recruit Count: 50

Registration Number: NCT04539236

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Cornell University, New York, New York, United States

and more 3 locations

A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions

Phase 2

Active, not recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Luspatercept

First Posted Date: 2020-07-20

Last Posted Date: 2023-10-12

Lead Sponsor: Celgene

Target Recruit Count: 30

Registration Number: NCT04477850

Locations: 🇯🇵
Local Institution - 203, Nagasaki-shi, Nagasaki, Japan
🇨🇳
Local Institution - 105, Guangzhou, China
🇨🇳
Local Institution - 103, Guangzhou, China

and more 21 locations

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Phase 3

Recruiting

Conditions: Myelodysplastic Syndromes (MDS)
Beta-thalassemia
Myeloproliferative Neoplasm(MPN)-Associated Myelofibrosis

Interventions: Drug: Luspatercept

First Posted Date: 2019-08-21

Last Posted Date: 2024-12-20

Lead Sponsor: Celgene

Target Recruit Count: 665

Registration Number: NCT04064060

Locations: 🇫🇷
Local Institution - 304, Pierre Benite cedex, France
🇫🇷
Local Institution - 308, Strasbourg, France
🇫🇷
Local Institution - 309, Toulouse Cedex 9, France

and more 140 locations

An Efficacy and Safety Study of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes (MDS) in Japanese Subjects Who Are Not Requiring Red Blood Cell Transfusion

Phase 2

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Luspatercept

First Posted Date: 2019-04-03

Last Posted Date: 2024-10-17

Lead Sponsor: Celgene

Target Recruit Count: 21

Registration Number: NCT03900715

Locations: 🇯🇵
Local Institution - 344, Nagasaki-shi, Nagasaki, Japan
🇯🇵
Local Institution - 331, Kamogawa, Japan
🇯🇵
Local Institution - 348, Kitakyushu, Japan

and more 16 locations

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

Phase 3

Active, not recruiting

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Luspatercept
Drug: Epoetin alfa

First Posted Date: 2018-09-24

Last Posted Date: 2024-11-20

Lead Sponsor: Celgene

Target Recruit Count: 363

Registration Number: NCT03682536

Locations: 🇺🇸
Local Institution - 114, Salt Lake City, Utah, United States
🇺🇸
Local Institution - 107, Berkeley, California, United States
🇺🇸
Local Institution - 115, San Diego, California, United States

and more 223 locations

A Study to Determine the Efficacy and Safety of Luspatercept in Adults With Non Transfusion Dependent Beta (β)-Thalassemia

Phase 2

Completed

Conditions: Thalassemia

Interventions: Other: Placebo
Drug: Luspatercept
Other: Best Supportive Care (BSC)

First Posted Date: 2017-11-17

Last Posted Date: 2023-12-20

Lead Sponsor: Celgene

Target Recruit Count: 145

Registration Number: NCT03342404

Locations: 🇬🇷
Local Institution - 102, Athens, Greece
🇺🇸
Children's Hospital and Research Center at Oakland, Oakland, California, United States
🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States

and more 13 locations

A Safety and Efficacy Study to Evaluate Luspatercept in Subjects With Myeloproliferative Neoplasm-associated Myelofibrosis Who Have Anemia With and Without Red Blood Cell-transfusion Dependence

Phase 2

Completed

Conditions: Anemia
Primary Myelofibrosis

Interventions: Drug: Luspatercept

First Posted Date: 2017-06-21

Last Posted Date: 2023-08-24

Lead Sponsor: Celgene

Target Recruit Count: 95

Registration Number: NCT03194542

Locations: 🇺🇸
Local Institution - 109, Cleveland, Ohio, United States
🇺🇸
Local Institution - 100, Houston, Texas, United States
🇺🇸
MD Anderson Cancer Center The University of Texas, Houston, Texas, United States

and more 44 locations

A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Phase 3

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Other: Placebo
Drug: Luspatercept

First Posted Date: 2015-12-15

Last Posted Date: 2021-12-17

Lead Sponsor: Celgene

Target Recruit Count: 229

Registration Number: NCT02631070

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇩🇪
Universitatsklinikum Bonn, Bonn, Germany

and more 71 locations

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

Phase 3

Completed

Conditions: Erythrocyte Transfusion
Beta-Thalassemia

Interventions: Other: Placebo
Drug: Luspatercept

First Posted Date: 2015-11-13

Last Posted Date: 2023-04-18

Lead Sponsor: Celgene

Target Recruit Count: 336

Registration Number: NCT02604433

Locations: 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇦🇺
Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide, South Australia, Australia
🇬🇷
Laiko General Hospital of Athens, Ampelokipi - Athens, Greece

and more 73 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy