A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Antifungal Prophylaxis With Posaconazole.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ciceri Fabio
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Graft-versus-host disease-free, relapse-free survival (GRFS)
研究概览
简要总结
SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole.
The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myelodysplastic syndromes or acute leukemia
- •Activation of an alternative donor search by the Italian Bone Marrow Donor Registry (IBMDR) with absence of a 10/10 Human Leukocyte Antigens (HLA) matched unrelated donor
- •Unavailability of a HLA-matched related donor (MRD)
- •Performance status : Eastern Cooperative Oncology Group (ECOG) <3
- •Written and signed informed consent
- •Life expectancy not severely limited by concomitant illness.
排除标准
- •Women of child-bearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective method of birth control such as condoms, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), vasectomised partner on treatment and for at least 6 months thereafter.
- •Pregnant or nursing (lactating) women.
- •Known allergies, hypersensitivity, or intolerance to any experimental drugs.
- •Any active, uncontrolled infection.
研究组 & 干预措施
Single Arm Treatment
Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
干预措施: Conditioning treatment "Thiotepa-Treosulfan-Fludarabine" (Drug)
Single Arm Treatment
Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
干预措施: PBSC graft (Procedure)
Single Arm Treatment
Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
干预措施: GvHD prophylaxis (Drug)
Single Arm Treatment
Conditioning treatment "Thiotepa-Treosulfan-Fludarabine"; PBSC graft; GvHD prophylaxis; Primary antifungal prophylaxis.
干预措施: Primary antifungal prophylaxis (Drug)
结局指标
主要结局
Graft-versus-host disease-free, relapse-free survival (GRFS)
时间窗: 2 years
GRFS events is defined as the first event among grade III-IV acute Graft vs. Host Disease (GVHD), severe chronic GVHD, relapse and death from any cause
次要结局
- Efficacy of antifungal prophylaxis strategy(85 days after transplantation)