Efficacy and safety of allogeneic hematopoietic cell transplantation using post-transplantation cyclophosphamide for graft-versus-host disease prophylaxis in higher-risk myelodysplastic syndrome, chronic myelomonocytic leukemia, and secondary AML patients

Asan Medical Center0 个研究点目标入组 113 人开始时间: 待定最近更新: 2019年8月26日

试验速览

暂无简介。

•MDS defined by WHO classification, CMML, or AML evolving from MDS
•?International Prognostic Scoring System (IPSS) > 1.0 or bone marrow blast = 5% at any time points before HCT or
•?AML progressed from MDS or
•?CMML with bone marrow blast = 5% at any time points before HCT
•Patients receiving first HCT
•Patients with appropriate hematopoietic cell donors
•?HLA-matched sibling donor
•?Unrelated donor
•?HLA-mismatched familial donor
•15 years old or older, , under 75 years
•Adequate performance status (Karnofsky score of 70 or more)
•Adequate hepatic function (AST or ALT < 3 x upper normal limits and bilirubin < 1.5 x upper normal limit).
•Adequate renal function (creatinine < 2.0 mg/dL or creatinine clearance = 50 mL/min)
•Adequate cardiac function (left ventricular ejection fraction = 50% on heart scan or echocardiogram)
•Adequate pulmonary function: DLCO, FEV1, and FVC = 45% predicted by pulmonary function tests
•Signed and dated informed consent must be obtained from both recipient and donor.

•Presence of significant active infection
•Presence of uncontrolled bleeding
•Any coexisting major illness or organ failure
•Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
•Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
•Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
•Presence of contraindications to cyclophosphamide (patients receiving pentostatin, symptomatic cystitis, urinary tract obstruction, with a history of hypersensitivity reactions to the component of the drug)

发起方