HCT With PTCy in Higher-risk MDS
Patients With MDS, Acute Myeloid Leukemia (AML) Evolving From MDS, and Chronic Myelomonocytic Leukemia (CMML)
About this trial
This is an interventional treatment trial for Patients With MDS, Acute Myeloid Leukemia (AML) Evolving From MDS, and Chronic Myelomonocytic Leukemia (CMML)
Eligibility Criteria
Inclusion Criteria: MDS defined by WHO classification, CMML, or AML evolving from MDS A. International Prognostic Scoring System (IPSS) > 1.0 or bone marrow blast ≥ 5% at any time points before HCT or B. AML progressed from MDS or C. CMML with bone marrow blast ≥ 5% at any time points before HCT Patients receiving first HCT Patients with appropriate hematopoietic cell donors A. HLA-matched sibling donor B. Unrelated donor C. 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. Exclusion Criteria: 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)
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Experimental
PTCy
Patients who receive post-transplantation cyclophosphamide