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

ConditionHSCT
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Luspatercept treatmentExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: