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

NCT07450313 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2025133
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HSCT

Keywords

anemia，HSCT

Outcome Measures

Primary Outcomes (1)

• Cumulative volume of red blood cell transfusions

  28 days post-HSCT

Secondary Outcomes (10)

• Cumulative volume of red blood cell transfusions

  56 days post-transplantation

• Platelet and neutrophil counts

  2 months post-HSCT

• Incidence of poor graft function (PGF).

  one year post-HSCT

• Serum/bone marrow GATA1,and GDF11 levels

  2 months post-HSCT

• Levels of inflammatory factors

  2 months post-HSCT

Study Arms (1)

Luspatercept treatment

EXPERIMENTAL

Drug: Luspatercept

Interventions

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.

Luspatercept treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.
• \. Expected survival after transplantation exceeds 1 month.
• \. Age 18-60 years.
• \. Hemoglobin ≤60 g/L on day 0 after transplantation.
• \. Eastern Cooperative Oncology Group (ECOG) score 0-2.
• \. Able to independently sign the informed consent form.
• \. 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.

You may not qualify if:

• \. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;
• \. Severe organic damage: hepatic or renal impairment;
• \. 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;
• \. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;
• \. Inability or unwillingness to sign the consent form;
• \. Participation in other transplant-related clinical studies;
• \. 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Interventions

luspatercept

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 4, 2026
• Study Start: March 14, 2026
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 14, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02