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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Cumulative volume of red blood cell transfusions [Срок оценки: 28 days post-HSCT]

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07450313 · IIT2025133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗