Post-transplant Cyclophosphamide in Wiskott-Aldrich Syndrome
Ключови думи
Резюме
Описание
Patients were enrolled in CIP-2015 Protocol at the Capital Institute of Pediatrics (Beijing). The conditioning regimen consisted of fludarabine (40 mg/m2) from days −6 to −3, and Busulfan was administered intravenously for 4 days, from days -5 to -2,using dose targeting based on therapeutic drug monitoring. Thymoglobulin (Sanofi, Cambridge, MA) 7.5 to 10 mg/kg (cumulative dose over 4 days) was administered over 4 days, from days -5 to -2. Bone marrow (BM) and PBSC were infused on day 0, followed by post-transplant CY (50 mg/kg/day, on days +3 and +4). To protect against hemorrhagic cystitis, MESNA (2-mercaptoethane sodium sulfonate) was administered at 150% of the CY dose. Post grafting immunosuppression with mycophenolate mofetil and tacrolimus commenced on day +5 and extended until days +28 and +84, respectively. Tacrolimus was tapered off by day +90 if there was no GVHD.
Дати
Последна проверка: | 05/31/2017 |
Първо изпратено: | 06/21/2017 |
Очаквано записване подадено: | 06/21/2017 |
Първо публикувано: | 06/25/2017 |
Изпратена последна актуализация: | 06/25/2017 |
Последна актуализация публикувана: | 06/26/2017 |
Действителна начална дата на проучването: | 03/09/2015 |
Приблизителна дата на първично завършване: | 03/09/2017 |
Очаквана дата на завършване на проучването: | 07/09/2020 |
Състояние или заболяване
Интервенция / лечение
Procedure: cyclophosphamide
Фаза
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 5 Months Да се 5 Months |
Полове, допустими за проучване | All |
Метод за вземане на проби | Probability Sample |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: -Patients diagnosed with Wiskott-Aldrich Syndrome with indication of Hematopoietic stem cell transplantation Exclusion Criteria: - without indication of Hematopoietic stem cell transplantation |
Резултат
Първични изходни мерки
1. Rate of aGvHD [3month]