Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial). MDS0519 - MDS0519

Fondazione Gimema Franco Mandelli Onlus0 个研究点目标入组 274 人开始时间: 2024年6月4日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and IPSS-R intermediate to very-high, Age 18-70 years, Previously untreated for HR-MDS, HSCT – eligible, Life expectancy greater than or equal to 3 months, Signed written informed consent according to ICH/EU/GCP and national local laws, Eastern Cooperative Oncology Group Performance Status Grade of 0-2

•Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB), concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma), severe renal, cardiac, liver or lung impairment, pregnant or lactating or potentially fertile (both males and females), who have not agreed to avoid pregnancy during the trial period; Women of childbearing potential and men must agree to use effective contraception during and up to 3 months after treatment with azacitidine., HIV infection; active, uncontrolled HCV or HBV infections or liver cirrhosis, clinically relevant neurological or psychiatric diseases, hypersensitivity (known or suspected) to AZA, prior Treatments: a) prior investigational drugs (within 30 days); b) radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months; c) growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days; d) androgenic hormones during the previous 14 days; e) prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy, administered to treat MDS.

发起方

Fondazione Gimema Franco Mandelli Onlus