Идёт набор NCT07362810

G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

Фаза II С лечением Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB) Hematopoetic Stem Cell Transplantation Hemato-oncologic Patients

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: G-CSF+IL-11, G-CSF Granulocyte-Colony Stimulating Factor.
Кому может быть актуально: Состояния в реестре: Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation, Hemato-oncologic Patients. Базовые параметры: 18 лет — 70 лет · Все.
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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Impact of G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation

Обзор

Autologous hematopoietic stem cell transplantation(auto-HSCT) plays an important role in treating hematologic malignancies. Mobilization and collection of peripheral blood stem/progenitor cells is the key to successful autologous hematopoietic stem cell transplantation. Currently mobilization regimens are not enough in increasing the yield of megakaryocytic or erythroid stem/progenitor cells, resulting in a delay of hematopoietic reconstitution of platelets and erythrocytes. IL-11 and G-CSF have a synergistic role in mobilizing peripheral blood stem cells towards megakaryocytic or erythroid stem/progenitor cells in a preclinical study. Furthermore, a single-center, small cohort, prospective clinical study that has been completed in China(ChiCTR2500100054), which showed that after five days of mobilization, the combination of G-CSF and IL-11 significantly increased the number and proportion of functional megakaryocytic/erythroid progenitor cells in the peripheral blood mononuclear cells of patients, and also significantly shortened the time for platelet engraftment after transplantation, and also reduced the demand for red blood cell and platelet transfusions compared to G-CSF alone. A multi-center, prospective random clinical study is essential to compare the efficacy and safety of novel mobilization regimen with IL-11 plus G-CSF to G-CSF alone.

Вмешательства

Препарат G-CSF+IL-11
rhG-CSF 5 μg/kg/day for 6 days plus rhIL-11 50 μg/kg/day for 5 days
Препарат G-CSF Granulocyte-Colony Stimulating Factor
rhG-CSF 5 μg/kg/day subcutaneously for 6 days

Первичные конечные точки

hematopoietic engraftment time (including granulocyte engraftment and platelet engraftment) [Срок оценки: Data on engraftment will be collected daily from stem cell infusion (Day 0) until the occurrence of both engraftment events or up to a maximum of 100 days, whichever comes first.]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: Adverse events are monitored from the time of enrollment (first study intervention) through the end of the study, with an expected average follow-up of 12 months.]

Вторичные конечные точки (1)

progression-free survival (PFS) and overall survival (OS) [Срок оценки: PFS: From randomization to disease progression or death from any cause, whichever occurs first, through study completion, an average of 1 year. OS: From randomization to death from any cause, through study completion, an average of 1 year.]

Критерии участия

Критерии включения

Adults (≥18 years) with newly diagnosed multiple myeloma or lymphoma
Suitable candidates for autologous hematopoietic stem cell transplantation (auto-HSCT)
Zubrod (ECOG) performance status < 4
Left ventricular ejection fraction (LVEF) > 40%
No uncontrolled arrhythmia or unstable cardiac disease
Corrected QT interval (QTc) < 470 ms
No symptomatic pulmonary disease, with acceptable pulmonary function tests
Serum alanine aminotransferase (ALT) < 4 × upper limit of normal (ULN)
Total bilirubin < 2 × upper limit of normal (ULN)