The Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery of Patients After sUCBT

Официальное название

An Exploratory Study to Assess the Safety and Efficacy of Coenzyme I for Injection in Promoting Hematopoietic Recovery After Single-unit Unrelated Cord Blood Transplantation in Patients With Hematological Malignancies

Обзор

To assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Подробное описание

A single-center, open-label, dose-escalation study to assess the safety and efficacy of coenzyme I for injection in promoting hematopoietic recovery after single-unit unrelated cord blood transplantation in hematological malignancies.

Вмешательства

• Препарат Coenzyme I for Injection
  Subjects received 21 consecutive days of intravenous infusion of Coenzyme I for injection, starting from the day of transplantation , and then continuously applied intravenously until 20 days post transplantation, with three dose groups: subjects #1-3 received one intravenous infusion per day containing 10 mg of Coenzyme I for injection, subjects #4-6 received one intravenous infusion per day containing 20 mg of Coenzyme I for injection, and subjects #7-12 received one intravenous infusion per d

Первичные конечные точки

• Adverse Event(AE) [Срок оценки: From the date of initial treatment to 30 days after transplantation]

Вторичные конечные точки (11)

• Neutrophil engraftment time [Срок оценки: 42 days post transplantation]
• Cumulative incidence of neutrophil engraftment on day 16 [Срок оценки: 16 days post transplantation]
• platelet engraftment time [Срок оценки: 180 days post transplantation]
• Cumulative incidence of platelet engraftment on day 60 [Срок оценки: 60 days post transplantation]
• Cumulative incidence of primary graft failure on day 30 [Срок оценки: 30 days post transplantation]
• Cumulative incidence of grade II-IV and III-IV acute GVHD on day 100 [Срок оценки: 100 days post transplantation]
• Cumulative incidence of transplant-related mortality on day 180 [Срок оценки: 180 days post transplantation]
• Cumulative incidence of relapse on day 180 [Срок оценки: 180 days post transplantation]
• Probability of overall survival [Срок оценки: 180 days post transplantation]
• Probability of leukemia-free survival [Срок оценки: 180 days post transplantation]
• Probability of GVHD-free relapse-free survival [Срок оценки: 180 days post transplantation]

Критерии участия

Критерии включения

• Age between 18 and 60 years (inclusive) at screening; gender is not restricted;
• Diagnosed with hematological malignancies to receive sUCBT for the first time;
• No severe organ failure and no active infections
• ECOG performance status of 0-2;
• Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.

Критерии исключения

• Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
• Pregnant patients;
• Patients and/or authorised family members who refuse to receive Coenzyme I for Injection;
• Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at undue risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive impairment;
• Participants in other clinical studies affecting hematopoietic recovery within 3 months;
• Those who are considered by the investigator to be unsuitable for enrolment (e.g., those who anticipate that the patient will not be able to adhere to the examination and treatment due to financial or other issues).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Хэфэй

Идентификаторы

NCT: NCT06558253 · coenzyme I for injection

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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