Идёт набор NCT07014943

High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma

Фаза II С лечением Primary Central Nervous System Lymphoma (PCNSL)

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: High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy.
Кому может быть актуально: Состояния в реестре: Primary Central Nervous System Lymphoma (PCNSL). Базовые параметры: 16 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

A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas

Обзор

The goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. It will learn about the safety and efficacy of combination therapy. The main question it aims to answer is: Efficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to ASCT in patients with CNSL. Participants will: Take gemcitabine (2.5 g/m²) was administered intravenously (IV) on Days -9 and -3, Busulfan (3.2 mg/kg) was given IV over 3 hours on Days -9 to -7, and thiotepa (5 mg/kg) was administered IV on Days -5, -4, and -3. Peripheral stem cells were infused on Day 0. Visit the clinic for checkups and tests in accordance with the International Primary CNS Lymphoma Group (IPCG). Researchers will observe the patients receiving GemBuTT regimen as conditioning therapy in CNSL.

Вмешательства

Препарат High dose Gemcitabine, Busulfan, and Thiotepa as conditioning therapy
Gemcitabine (2.5 g/m²) (Days -9 and -3), Busulfan (3.2 mg/kg) (Days -9 to -7), and Thiotepa (5 mg/kg) (Days -5, -4, and -3) were all administered intravenously. Peripheral stem cells were infused on Day 0.

Первичные конечные точки

PFS [Срок оценки: 2 years from ASCT]

Вторичные конечные точки (5)

OS [Срок оценки: 2 years post ASCT]
non-relapse mortality (NRM) [Срок оценки: 100 days]
Hematopoietic recovery [Срок оценки: 30 days]
Non-hematological adverse events (AEs) [Срок оценки: 2 months]
Lymphoma relapse or progression [Срок оценки: 2 years]

Критерии участия

Критерии включения

age between 18 and 70 years;
CNS status of complete remission (CR) or partial response (PR) as assessed by magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET/CT), or CSF analysis (if applicable);
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;
absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;
negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies/mL);
left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;
forced expiratory volume in one second (FEV1) ≥70%;
serum creatinine clearance ≥ 50 ml/min and/or serum creatinine ≤ 1.8 mg/dL;
serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) ≤ 3 times the upper limit of normal.