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Набор скоро начнётся NCT07552480

Clinical Study on the Preservation of Ovarian Function Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using Goserelin

Без фазы С лечением Allogeneic Haematopoietic Stem Cell Transplantation Malignant Hematologic Disease Ovarian Insufficiency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Goserelin.
Кому может быть актуально
Состояния в реестре: Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease, Ovarian Insufficiency. Базовые параметры: 14 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

This study is a prospective, multicenter, randomized controlled clinical trial planned to enroll 64 female patients with malignant hematologic diseases aged 14-50 years who are scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be divided into two groups based on the use of myeloablative conditioning: the myeloablative conditioning (MAC) group and the non-MAC conditioning group. The non-MAC group refers to a primary conditioning regimen where the main conditioning agents-busulfan (Bu) ≤ 6.4 mg/kg, melphalan (Mel) ≤ 140 mg/m², and thiotepa ≤ 10 mg/kg-are combined. Patients receiving this primary chemotherapy regimen will be assigned to the MAC group. Within each group (MAC or non-MAC), patients were randomly assigned 1:1 to either the experimental group (goserelin prophylaxis) or the control group using a random number table. The experimental group received a single 3.6 mg subcutaneous injection of goserelin 1-3 days prior to conditioning, in addition to the standard transplantation regimen. The control group did not receive goserelin prophylaxis. The primary endpoint was menstrual recovery rate at 6 months post-transplantation. Secondary endpoints included: incidence of premature ovarian insufficiency (POI); ovarian reserve function markers: anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) levels; other reproductive indicators: ovarian volume, endometrial thickness; Neutrophil/platelet engraftment time; Complications: incidence of acute/chronic graft-versus-host disease (aGVHD/cGVHD), EBV/CMV infection rates; Disease recurrence rate; Transplant-related mortality; Adverse event (AE) occurrence. This study aims to evaluate the efficacy and safety of goserelin in improving ovarian function following hematopoietic stem cell transplantation in patients with malignant hematologic diseases.

Вмешательства

  • Препарат Goserelin
    Subcutaneous injection of 3.6 mg of goserelin acetate once, administered 1 to 3 days prior to allogeneic haematopoietic stem cell transplantation.

Первичные конечные точки

  • Menstrual recovery rate six months after transplantation [Срок оценки: month 6]
Вторичные конечные точки (1)
  • Ovarian function; Safety [Срок оценки: month 6]

Критерии участия

Критерии включения

1\. Patients with malignant hematologic disorders scheduled for allogeneic hematopoietic stem cell transplantation (allo-HSCT); 2. Female patients aged 14 to 50 years, within reproductive age, with regular menstrual cycles prior to transplantation; 3. Patients or their legal representatives voluntarily participate and sign informed consent forms, demonstrating ability to understand and comply with all study procedures and requirements; 4. Expected survival exceeding 1 year to ensure sufficient time for monitoring menstrual recovery.

Критерии исключения

1\. Patients with severe dysfunction of vital organs such as the heart, liver, or kidneys, which may affect study outcomes or increase patient risk; 2. Patients with a history of allergy to goserelin or other related medications; 3. Patients who have already undergone menopause due to physiological or pathological factors; 4. Patients with a history of gynecological conditions (e.g., polycystic ovary syndrome, endometriosis) that may interfere with the assessment of menstrual recovery; 5. Patients currently participating in other clinical studies that may affect menstrual recovery; 6. Patients who refuse to participate in this clinical study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Китай · 5 центров
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • The First People's Hospital of Yunnan Province — Куньмин
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07552480 · UHCT260114

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗