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NCT Number: NCT07450313

The Efficacy and Safety of Luspatercept in Improving Early Anemia After HSCT

This study aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

This study aims to investigate whether the early post-transplant application of luspatercept can improve early anemia and transfusion dependency in patients with hematologic malignancies after hematopoietic stem cell transplantation. Meanwhile, the investigators aim to evaluate the safty of administration of luspatercept post-transplantation, and assess its impact on platelet and neutrophil engraftment, as well as its effect on the incidence of complications such as poor graft function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.
  • 2. Expected survival after transplantation exceeds 1 month.
  • 3. Age 18-60 years.
  • 4. Hemoglobin ≤60 g/L on day 0 after transplantation.
  • 5. Eastern Cooperative Oncology Group (ECOG) score 0-2.
  • 6. Able to independently sign the informed consent form.
  • 7. The informed consent form must be signed before the start of the study procedures. For individuals aged 18 years and above, the informed consent form should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is not conducive to treatment, the legal guardian or immediate family member should sign the informed consent form.

Exclusion criteria

  • 1. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;
  • 2. Severe organic damage: hepatic or renal impairment;
  • 3. Occurrence of any of the following within 6 months prior to the study: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, or cerebrovascular accident, including transient ischemic attack;
  • 4. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;
  • 5. Inability or unwillingness to sign the consent form;
  • 6. Participation in other transplant-related clinical studies;
  • 7. Other circumstances deemed by the investigator as potentially affecting the study or ethics, including drug allergies, patient non-compliance with study procedures, or involvement of the research center staff and their immediate relatives.

Treatment and study plan

Luspatercept

Drug

Subjects will be screened according to the inclusion and exclusion criteria. Eligible patients enrolled will receive treatment with Luspatercept at a dose of 1.0 mg/kg, administered subcutaneously as a single dose on day +3 after transplantation.

Primary outcomes

  1. Cumulative volume of red blood cell transfusions

    Time frame: 28 days post-HSCT

Secondary outcomes

  1. Cumulative volume of red blood cell transfusions

    Time frame: 56 days post-transplantation

  2. Platelet and neutrophil counts

    Time frame: 2 months post-HSCT

  3. Incidence of poor graft function (PGF).

    Time frame: one year post-HSCT

  4. Serum/bone marrow GATA1,and GDF11 levels

    Time frame: 2 months post-HSCT

  5. Levels of inflammatory factors

    Time frame: 2 months post-HSCT

    IL-1, IL-6, IFN-γ, TNF-α.

  6. Incidence of acute graft-versus-host disease (aGVHD).

    Time frame: one year post-HSCT

  7. Overall Survival

    Time frame: one year after HSCT

  8. disease-free survival

    Time frame: one year after HSCT

  9. cumulative incidence of relapse

    Time frame: one year after HSCT

  10. treatment-related mortality

    Time frame: one year after HSCT

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

A Clinical Study on the Efficacy and Safety of Luspatercept in Improving Early Anemia After Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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