HSCT
Conditions
Keywords
anemia，HSCT
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.
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
DRUGLuspatercept
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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative volume of red blood cell transfusions | 28 days post-HSCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cumulative incidence of relapse | one year after HSCT | — |
| treatment-related mortality | 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 | 2 months post-HSCT | IL-1, IL-6, IFN-γ, TNF-α. |
| Incidence of acute graft-versus-host disease (aGVHD). | one year post-HSCT | — |
| disease-free survival | one year after HSCT | — |
| Overall Survival | one year after HSCT | — |
Outcome results
None listed