Clinical Study on the Safety and Efficacy of Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression .

Официальное название

Clinical Study on the Safety and Efficacy of Unrelated Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression After Chemotherapy in Elderly Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) .

Обзор

The clinical study aims to evaluate the safety and efficacy of umbilical cord blood transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML

Подробное описание

The clinical study aims to evaluate the safety and efficacy of umbilical cord blood （HLA typing 0-3/10 match, TNC ≥ 3×10\^7/kg）transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML，UCB can be applied in one to multiple doses, and the minimum interval between two cord blood transfusions should be 2 weeks.

Вмешательства

• Биопрепарат Umbilical cord blood
  Umbilical cord blood transfusion should be performed 24 hours to 2 weeks after chemotherapy. One to multiple units of cord blood can be applied, and the minimum interval between two cord blood transfusions should be 2 weeks.

Первичные конечные точки

• Percentage of patients with bone marrow suppression grade < II. [Срок оценки: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
• hematological parameters like hemoglobin level(Hb) [Срок оценки: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
• hematological parameters like white blood cell count(WBC) [Срок оценки: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
• hematological parameters like platelet count(PLT) [Срок оценки: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]
• hematological parameters like neutrophil count(ANC) [Срок оценки: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.]

Вторичные конечные точки (2)

• Incidence of bleeding [Срок оценки: Up to 30 days after umbilical cord blood treatment]
• Incidence of infection [Срок оценки: Up to 30 days after umbilical cord blood treatment.]

Критерии участия

Критерии включения

• 1\) Ages 60-80 years , gender unlimited;
• 2\) Patients clinically diagnosed with MDS or AML;
• 3\) Completed chemotherapy and clinically diagnosed with bone marrow suppression grade 2 or above;
• 4\) Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
• 5\) Normal cardiac function;
• 6\) Patients with ECOG 0-2;
• 7\) Patients or their families have been informed and voluntarily signed a written informed consent form.

Критерии исключения

• 1\) Other factors that may cause abnormalities in white blood cells and neutrophils, such as concurrent infections, invasive procedures, etc.
• 2)Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia, etc.). Any unstable systemic diseases: including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association NYHA classification ≥ III,), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases.
• 3\) Any other uncontrolled active diseases that may interfere with participation in the trial;
• 4\) Concurrent diagnosis of malignant tumors in other organs;
• 5\) Concurrent diagnosis of other hematological disorders;
• 6\) Inability to understand or comply with the study protocol;
• 7\) Individuals deemed unsuitable for participation in this trial by the investigator.

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07201233 · UCB-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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