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Набира участници Фаза 2 NCT05088226

Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Peripheral Blood Stem Cell Transplantation

Спонсор: Chinese PLA General Hospital

Налично на: БГ
Обобщение
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute B cell Lymphoblast leukemia Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
Описание
Haploidenticl Peripheral blood Stem Cell Transplantation should be offered to eligible patients with Acute B cell Lymphoblast leukemia whenever feasible. To further improve the outcome of transplantation patients with Acute B cell Lymphoblast leukemia, we developed a modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide. In this study, we tested the efficacy and feasibility of the modified Bu/Cy conditioning regimen intensified by Ruxolitinib and Chidamide in patients with Acute B cell Lymphoblast leukemia undergoing allogeneic peripheral blood stem cell transplantation.
Кой може да участва
Inclusion Criteria: 1. high risk acute B cell lymphoblastic leukemia with the indications for allogeneic transplantation; 2. Have matched sibling donors, ≥8/10 HLA matched unrelated donors or haploidentical donors 3. All patients should aged 12 to 65 years; 4. Liver function: ALT and AST≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 5. Renal function: creatinine ≤the upper limit of normal; 6. Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 8. Have signed informed consent. Exclusion Criteria: 1. pregnant women; 2. Patients with mental illness or other states unable to comply with the protocol; 3. ALL patients with Ph positive;
Интервенции
Ruxolitinib combined with Chidamide.
DRUG
Места на провеждане 1
Китай (1)
Chinese PLA General Hospital
Beijing , Beijing Municipality
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Years
Максимална възраст
65 Years
Здрави доброволци
Не
Начална дата
01.12.2021
Крайна дата
01.06.2031
Регистрационен номер
NCT05088226
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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