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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HSCT
• Intervention / Treatment: Drug: Luspatercept

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luspatercept treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative volume of red blood cell transfusions	28 days post-HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival		one year after HSCT
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	IL-1, IL-6, IFN-γ, TNF-α.	2 months post-HSCT
Incidence of acute graft-versus-host disease (aGVHD).		one year post-HSCT
disease-free survival		one year after HSCT
cumulative incidence of relapse		one year after HSCT
treatment-related mortality		one year after HSCT

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 14, 2026
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): June 14, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anemia，HSCT
• Additional Relevant MeSH Terms: luspatercept
• Other Study ID Numbers: IIT2025133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No