A phase II trial of allogeneic peripheral blood stem cell transplantation from family haploidentical donors in patients with myelodisplastic syndrome and acuteleukemia under primary antifungal prophylaxis with posaconazole - SIR-POSA

OSPEDALE SAN RAFFAELE0 个研究点目标入组 82 人开始时间: 2021年9月3日最近更新: 2021年9月13日

适应症

试验速览

暂无简介。

•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 HLA matched unrelated donor
•Unavailability of a HLA-matched related donor (MRD)
•Performance status : ECOG = 3
•Written and signed informed consent
•Life expectancy not severely limited by concomitant illness.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•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, IUDs (intrauterine devices), 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.

发起方

OSPEDALE SAN RAFFAELE