Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Официальное название

Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)

Обзор

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.

Подробное описание

Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15\~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR \<10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.

Вмешательства

• Препарат Fludarabine, busulfan and melphalan
  FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
• Препарат Fludarabine and Busulfan
  FLudarabine 150mg/m2 + Busulfan 12.8mg.kg

Первичные конечные точки

• disease-free survival [Срок оценки: 2 year]

Вторичные конечные точки (4)

• overall survival [Срок оценки: 2 year]
• incidence of relapse [Срок оценки: 2 year]
• non relapse mortality [Срок оценки: day 100]
• non relapse mortality [Срок оценки: 2 year]

Критерии участия

Критерии включения

• acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission
• myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation
• patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors
• inform consent provided

Критерии исключения

• AML patients with active CNS or extramedullary diseases
• patients with active viral, bacterial or fungal infection
• patients with hepatitis B virus >1X103 copy/ml
• patients with abnormal liver function, renal function, respiratory or cardiac dysfunction
• patients with uncontrolled mental disorders
• patients with HIV

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Fujian Medical University Union Hospital — Фучжоу
• Zhongshan Hospital, Xianmen University — Xiamen
• 923th Hospital PLA — Nanning
• First Affiliated Hospital of Nanjin Medical Unviersity — Nanjin
• First Affiliatied Hospital of Soochow University — Сучжоу
• Ruijin Hospital — Шанхай
• Shanghai No10 Hospital — Шанхай
• 920th Hospital PLA — Куньмин
• … и ещё 1 центр

Идентификаторы

NCT: NCT05991908 · MBF-FB4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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