Reduced ATG Plus Mini PTCy for GVHD Prophylaxis in Haplo-SCT

Официальное название

Reduced-dose Anti-thymocyte Globulin Plus Mini-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT for Hematologic Malignancy

Обзор

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is regarded as a curative therapy for a variety of hematological malignancies and nonmalignant diseases. However, donor limitations have restricted the widespread use of allo-HSCT for a long period. The development and success of haploidentical allografts worldwide makes "everyone has a donor" a reality. In the past two decades, researchers have established several haploidentical HSCT (haplo-HSCT) protocols based on different approaches to induce immune tolerance. The representative approaches for haplo-HSCT without in vitro. T cell depletion include granulocyte colony-stimulating factor (G-CSF) plus Anti-human Thymocyte Immunoglobulin (ATG) based (Beijing Protocol) and post-transplantation cyclophosphamide based (PT-Cy, Baltimore Protocol) protocols. Both of two protocols have common problems that need to be solved, including infection transplantation related mortality and disease relapse. The main aim of this study is to explore whether the combined protocol can improve the efficacy of haploidentical transplantation further.

Вмешательства

• Препарат Reduced ATG plus mini PTCy
  The conditioning protocol comprises cytarabine (Ara-C) (4 g/m2/day, days -9), busulfan (Bu) (3.2 mg/kg/day, days -8 to -6), cyclophosphamide (Cy) (1.8 g/m2/kg, days -5 and -4), simustine (250 mg/m2, day -3) and r-ATG (total 7.5mg/kg ,from days -5 to -2). Mini PTCy 14.5mg/kg/day will be given on day +3 and +4.

Первичные конечные точки

• Non-relapse mortality [Срок оценки: 100 days]

Вторичные конечные точки (4)

• Regimen related toxicity [Срок оценки: 30 days post transplantation]
• Engraftment [Срок оценки: Within 30 days post transplant. Myeloid engraftment was defined as the first of three consecutive days with an ANC 0.5×109 /L, and platelet engraftment was defined as the day the platelet count met or exceeded 20×10^9 /L without transfusion for a week.]
• Disease relapse [Срок оценки: 1 year post transplantation]
• Disease free survival [Срок оценки: 1 year post transplantation]

Критерии участия

Критерии включения

• Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
• No gender limit, aged 12 - 65 years;
• Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
• Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
• Baseline organ function tests meet the following criteria:

(1) Left ventricular ejection fraction (LVEF) > 55%; (2) Serum creatinine ≤ 1.5 × upper limit of normal (ULN).

Критерии исключения

• Patients with severe dysfunction of brain, heart, kidney or liver;
• Those in refractory malignant status;
• Patients with other malignancies requiring treatment;
• Presence of uncontrolled severe active infection clinically;
• Expected survival period of less than 3 months;
• History of severe allergic reactions;
• Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Peking University People'S Hospital — Пекин

Идентификаторы

NCT: NCT06984536 · Lower ATG plus miniPTCy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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