None listed
Conditions
Interventions
Drug : • Conditioning regimen
? Busulfan 3.2 mg/kg/day i.v. daily
- For 4 days (days -7 to -4) in patients aged <
55 years
- For 2 days (days -7 and -6) in patients aged = 55 years
? Fludarabine 30 mg/m2/day i.v. daily on days -7 to -2 (for 6 days)
• Harvest and infusion of donor hematopoietic cells
? Har
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •GVHD-free, , relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| engraftment;non-relapse mortality;relapse;graft-versus-host disease;donor chimerism;immune reconstitution;infections;survivals (overall and event-free) | — |
Countries
Korea, Republic of
Contacts
Public Contactkyunghwa Lee
Asan Medical Center
Outcome results
None listed