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

Not Applicable

Not yet recruiting

• Conditions: Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0004151
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2019
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

•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.

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)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•GVHD-free, , relapse-free survival

Secondary Outcome Measures

Name	Time	Method
engraftment;non-relapse mortality;relapse;graft-versus-host disease;donor chimerism;immune reconstitution;infections;survivals (overall and event-free)