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

Phase II Interventional HSCT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Luspatercept.
Who it may be relevant to
Registry conditions: HSCT. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug Luspatercept
    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 outcome measures

  • Cumulative volume of red blood cell transfusions [Time frame: 28 days post-HSCT]
Secondary outcome measures (10)
  • Cumulative volume of red blood cell transfusions [Time frame: 56 days post-transplantation]
  • Platelet and neutrophil counts [Time frame: 2 months post-HSCT]
  • Incidence of poor graft function (PGF). [Time frame: one year post-HSCT]
  • Serum/bone marrow GATA1,and GDF11 levels [Time frame: 2 months post-HSCT]
  • Levels of inflammatory factors [Time frame: 2 months post-HSCT]
  • Incidence of acute graft-versus-host disease (aGVHD). [Time frame: one year post-HSCT]
  • Overall Survival [Time frame: one year after HSCT]
  • disease-free survival [Time frame: one year after HSCT]
  • cumulative incidence of relapse [Time frame: one year after HSCT]
  • treatment-related mortality [Time frame: one year after HSCT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07450313 · IIT2025133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗