A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India

Last updated: November 15, 2024
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

4

Condition

Anemia

Myelodysplastic Syndromes (Mds)

Thalassemia

Treatment

Luspatercept

Clinical Study ID

NCT05891249
CA056-023
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of luspatercept in participants who require regular blood cell transfusions due to b-thalassemia and myelodysplastic syndromes in India

Eligibility Criteria

Inclusion

Inclusion Criteria:

β-Thalassemia Cohort

  • Documented diagnosis of β-thalassemia or hemoglobin (Hb E/β-thalassemia). (β-thalassemia with mutation and/or multiplication of alpha [α] globin is allowed).

  • Regularly transfused, defined as 6 RBC units to 20 RBC units in the 24 weeks priorto enrollment and no transfusion-free period for > 35 days during that period.

MDS-RS Cohort

  • Participant has documented diagnosis of MDS according to World Health Organization (WHO) (2016)/French-American-British FAB classification that meets revisedInternational Prognostic Scoring System (IPSS-R) classification of very low, low, orintermediate risk disease and the following criteria: i) RS ≥ 15% of erythroidprecursors in bone marrow. If the SF3B1 mutation is present, RS ≥ 5% will beincluded.

ii) Less than 5% blasts in bone marrow and < 1% peripheral blood blasts. iii) Peripheral blood white blood cell (WBC) count < 13,000/ microliters (μL).

  • If the participant was previously treated with erythropoiesis-stimulating agents (ESAs) or granulocyte colony-stimulating factor (G-CSF)/granulocyte-macrophagecolony-stimulating factor (GM-CSF), both agents must have been discontinued ≥ 4weeks prior to the date of enrollment.

Exclusion

Exclusion Criteria:

β-Thalassemia Cohort

  • A diagnosis of Hb S/β-thalassemia or α-thalassemia (for exampe, Hemoglobin H).

  • Deep vein thrombosis (DVT) or stroke requiring medical intervention ≤ 24 weeks priorto enrollment.

  • Use of chronic anticoagulant therapy is excluded unless the treatment stopped atleast 28 days prior to enrollment. Anticoagulant therapies used for prophylaxis forsurgery or high-risk procedures as well as low-molecular-weight (LMW) heparin forsuperficial venous thrombosis and chronic aspirin are allowed.

  • Cytotoxic agents or immunosuppressants or immunomodulatory drugs (IMiDs) ≤ 28 daysprior to enrollment (ie, antithymocite globulin or cyclosporine or thalidomide).

MDS-RS Cohort

  • MDS associated with del 5q cytogenetic abnormality.

  • Secondary MDS, that is, MDS that is known to have arisen as the result of chemicalinjury or treatment with chemotherapy and/or radiation for other diseases.

  • Participant has known clinically significant anemia due to iron, vitamin B12, orfolate deficiencies; autoimmune or hereditary hemolytic anemia; or gastrointestinalbleeding.

  • Iron deficiency to be determined by serum ferritin ≤ 15 micrograms per liter (μg/L)and additional testing if clinically indicated (for example, calculated transferrinsaturation [iron/total iron binding capacity ≤ 20%] or bone marrow aspirate [BMA]stain for iron).

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Luspatercept
Phase: 4
Study Start date:
June 05, 2023
Estimated Completion Date:
April 13, 2026

Connect with a study center

  • All India Institute of Medical Sciences

    New Delhi, Delhi 110029
    India

    Active - Recruiting

  • Local Institution - 0001

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Local Institution - 0011

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Local Institution - 0002

    Ahmedabad, Gujarat 380009
    India

    Active - Recruiting

  • Vedanta Institute Of Medical Sciences

    Ahmedabad, Gujarat 380009
    India

    Active - Recruiting

  • Local Institution - 0012

    Bengaluru, Karnataka 560027
    India

    Site Not Available

  • Local Institution - 0014

    Noida, Uttar Pradesh 201303
    India

    Site Not Available

  • Local Institution - 0007

    Kolkatta, West Bangal 700014
    India

    Active - Recruiting

  • Nilratan Sirkar Medical College and Hospital

    Kolkatta, West Bangal 700014
    India

    Active - Recruiting

  • Gauhati Medical College and Hospital

    Assam, 781032
    India

    Active - Recruiting

  • Local Institution - 0005

    Assam, 781032
    India

    Active - Recruiting

  • HealthCare Global Enterprises Ltd. Hospital

    Bangalore, 560027
    India

    Active - Recruiting

  • Local Institution - 0003

    Bangalore, 560027
    India

    Active - Recruiting

  • Local Institution - 0004

    Chandigarh, 160012
    India

    Site Not Available

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012
    India

    Active - Recruiting

  • Local Institution - 0010

    Delhi, 110085
    India

    Active - Recruiting

  • Rajiv Gandhi Cancer Institute And Research Centre

    Delhi, 110085
    India

    Active - Recruiting

  • Local Institution - 0006

    Hyderabad, 500034
    India

    Completed

  • Local Institution - 0009

    Kolkata, 700156
    India

    Site Not Available

  • KEM Hospital and Seth G S Medical College

    Mumbai, 400012
    India

    Active - Recruiting

  • Local Institution - 0008

    Mumbai, 400012
    India

    Active - Recruiting

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